Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Analytics Laboratories, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
73 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1986-05-29 | 29 | 0 |
| K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1986-03-14 | 49 | 0 |
| K860213 | ALBUMIN REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1986-02-11 | 20 | 0 |
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | Bio-Analytics Laboratories, Inc. | 1985-05-20 | 35 | 0 |
| K851513 | ULTRA-VIOLET BUN REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1985-05-20 | 35 | 0 |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1985-03-05 | 14 | 0 |
| K832771 | ERYTHROCYTE TEST | Bio-Analytics Laboratories, Inc. | 1983-10-28 | 73 | 0 |
| K832567 | ACETAMINOPHEN(PARACETAMOL | Bio-Analytics Laboratories, Inc. | 1983-09-12 | 41 | 0 |
| K831414 | COLORIMETRIC BUN | Bio-Analytics Laboratories, Inc. | 1983-06-16 | 45 | 0 |
| K821934 | BIO-CAL OPERATION CHECK KIT | Bio-Analytics Laboratories, Inc. | 1982-07-20 | 21 | 0 |
| K813431 | SALICYLATES | Bio-Analytics Laboratories, Inc. | 1982-03-25 | 107 | 0 |
| K813469 | LIPID PROFILE | Bio-Analytics Laboratories, Inc. | 1981-12-31 | 20 | 0 |
| K810087 | UREA NITROGEN, KINETIC | Bio-Analytics Laboratories, Inc. | 1981-02-26 | 44 | 0 |
| K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT | Bio-Analytics Laboratories, Inc. | 1981-01-28 | 15 | 0 |
| K810088 | URIC ACID (TPTZ) COLORINMETRIC | Bio-Analytics Laboratories, Inc. | 1981-01-28 | 15 | 0 |
| K810085 | IRON KIT | Bio-Analytics Laboratories, Inc. | 1981-01-28 | 15 | 0 |
| K810086 | IRON & TICB | Bio-Analytics Laboratories, Inc. | 1981-01-28 | 15 | 0 |
| K810084 | MAGNESIUM KIT | Bio-Analytics Laboratories, Inc. | 1981-01-26 | 13 | 0 |
| K810082 | ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT | Bio-Analytics Laboratories, Inc. | 1981-01-26 | 13 | 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