Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Analytical Products, Inc. — Predicate Candidate Screening
57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
98 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924814 | API 20E/UNISCEPT 20E | Analytical Products, Inc. | 1993-03-11 | 167 | 0 |
| K923684 | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC | Analytical Products, Inc. | 1992-12-03 | 133 | 0 |
| K922926 | API UNISCEPT KB/TYPE 2 AND 3 | Analytical Products, Inc. | 1992-10-13 | 118 | 0 |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Analytical Products, Inc. | 1990-09-10 | 160 | 0 |
| K901390 | DMAC INDOLE REAGENT | Analytical Products, Inc. | 1990-04-16 | 21 | 0 |
| K895796 | API UNISCEPT KB | Analytical Products, Inc. | 1989-11-13 | 46 | 0 |
| K884509 | MODIFICATION MIC/API UNISCEPT(R) | Analytical Products, Inc. | 1988-11-22 | 26 | 0 |
| K884510 | MODIFICATION MICRO-MIC | Analytical Products, Inc. | 1988-11-22 | 26 | 0 |
| K880598 | MODIFICATIONS TO API UNISCEPT (R) KB | Analytical Products, Inc. | 1988-03-23 | 41 | 0 |
| K874466 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC | Analytical Products, Inc. | 1987-12-09 | 37 | 0 |
| K865062 | ALADIN (TM) | Analytical Products, Inc. | 1987-03-25 | 91 | 0 |
| K870663 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC | Analytical Products, Inc. | 1987-03-23 | 32 | 0 |
| K864891 | API UNISCEPT (TM) KB | Analytical Products, Inc. | 1987-02-20 | 67 | 0 |
| K862543 | DYNEX CO2/2000, CO2 ANALYZER | Analytical Products, Inc. | 1986-07-15 | 12 | 0 |
| K860369 | API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC | Analytical Products, Inc. | 1986-03-11 | 36 | 0 |
| K853544 | QUAD FERM + | Analytical Products, Inc. | 1985-09-05 | 10 | 0 |
| K850982 | CTAPI - NEISSERA SCREEN | Analytical Products, Inc. | 1985-03-29 | 18 | 0 |
| K850347 | API UNISCEPT KB | Analytical Products, Inc. | 1985-03-26 | 57 | 0 |
| K844159 | API UNISCEPT MIC 100UL | Analytical Products, Inc. | 1984-12-14 | 51 | 0 |
| K843360 | ARTAP ARTERIAL BLOOD SAMPLING DEVICE | Analytical Products, Inc. | 1984-10-31 | 64 | 0 |
| K843733 | API UNISCEPT KB | Analytical Products, Inc. | 1984-10-24 | 30 | 0 |
| K843732 | API UNISCEPT MIC | Analytical Products, Inc. | 1984-10-24 | 30 | 0 |
| K842839 | SERIMM SURE ASO-CHEK CONTROL SERUM | Analytical Products, Inc. | 1984-08-23 | 34 | 0 |
| K833988 | API STAPHASE III | Analytical Products, Inc. | 1983-12-22 | 34 | 0 |
| K832981 | ELECTRODES FOR BLOOD GAS ANALYZERS | Analytical Products, Inc. | 1983-10-28 | 56 | 0 |
| K832779 | REFEREE BLOOD GAS ANALYZER-ELECTRODES | Analytical Products, Inc. | 1983-10-14 | 59 | 0 |
| K831462 | API UNISCEPT PLUS 140 INOCULATOR | Analytical Products, Inc. | 1983-08-12 | 98 | 0 |
| K831341 | API UNISCEPT PLUS AUTOINOCULATOR | Analytical Products, Inc. | 1983-06-02 | 38 | 0 |
| K830525 | API 20GP | Analytical Products, Inc. | 1983-05-18 | 90 | 0 |
| K831032 | API ANAIDENT | Analytical Products, Inc. | 1983-05-05 | 36 | 0 |
| K830180 | REFEREE BRAND CO-OXIMETER REAGENTS | Analytical Products, Inc. | 1983-04-08 | 80 | 0 |
| K830286 | YEAST IDENT | Analytical Products, Inc. | 1983-04-05 | 68 | 0 |
| K830211 | API TB-IDENT* | Analytical Products, Inc. | 1983-03-24 | 59 | 0 |
| K830181 | REFEREE BLOOD GAS ANALYZER CONTROLS | Analytical Products, Inc. | 1983-02-28 | 41 | 0 |
| K823785 | API MDS* | Analytical Products, Inc. | 1983-01-09 | 24 | 0 |
| K821907 | NEIDENT* | Analytical Products, Inc. | 1982-07-22 | 24 | 0 |
| K821338 | SALMONELLA I.D. | Analytical Products, Inc. | 1982-05-28 | 23 | 0 |
| K821337 | SHIGELLA I.D. | Analytical Products, Inc. | 1982-05-28 | 23 | 0 |
| K821339 | SALMONELLA POLY | Analytical Products, Inc. | 1982-05-27 | 22 | 0 |
| K820785 | ASO SURE | Analytical Products, Inc. | 1982-04-08 | 16 | 0 |
| K820786 | ASO SURE PLUS | Analytical Products, Inc. | 1982-04-08 | 16 | 0 |
| K811982 | STAPHASE* | Analytical Products, Inc. | 1981-07-28 | 15 | 0 |
| K811998 | STAPH-IDENT | Analytical Products, Inc. | 1981-07-28 | 14 | 0 |
| K810762 | API TURBICITY STANDARD | Analytical Products, Inc. | 1981-04-03 | 11 | 0 |
| K801951 | API-CTS STREPTOCOCCUS | Analytical Products, Inc. | 1980-09-26 | 39 | 0 |
| K792447 | REFEREE BFT BLOOD FOR TONOMETRY | Analytical Products, Inc. | 1979-12-27 | 27 | 0 |
| K791222 | API 20E REAGENT QC | Analytical Products, Inc. | 1979-08-22 | 50 | 0 |
| K790281 | DIAGNOSTIC SET, LIPO-FRAX | Analytical Products, Inc. | 1979-03-21 | 36 | 0 |
| K781567 | API ZYM | Analytical Products, Inc. | 1978-12-20 | 97 | 0 |
| K781283 | READER, INOCULUM, STDIZED. | Analytical Products, Inc. | 1978-08-14 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda