FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Baker Instructions with 10 510(k) clearances. The most recent is a 510(k) clearance dated Sep 7, 1988: SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER.
| Date | Record | Source |
|---|---|---|
| Sep 7, 1988 | SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERK882612 · GKZ | 510(k) clearances |
| Oct 20, 1987 | BAKER TDM THEOPHYLLINE ASSAYK873596 · KLS | 510(k) clearances |
| Mar 31, 1987 | SYSTEM 9000 AUTOMATED CELL COUNTERK870603 · GKL | 510(k) clearances |
| Nov 4, 1985 | UCD URINE SPECIMEN COLLECTORK854173 · KNX | 510(k) clearances |
| May 2, 1985 | SYSTEM 8000 CELL COUNTERK850386 · GKL | 510(k) clearances |
| Nov 7, 1983 | SPIRIT CHEMISTRY SYSTEMK833116 · JJE | 510(k) clearances |
| Oct 4, 1983 | ENCORE CHEMISTRY ANALYZERK832716 · JJG | 510(k) clearances |
| Apr 5, 1983 | ENCORE CHEMISTRY ANALYZERK830641 · JJG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
