Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reagents Applications, Inc. — Predicate Candidate Screening
63 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
72 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982056 | RAICHEM CO2 REAGENT | Reagents Applications, Inc. | 1998-06-24 | 15 | 0 |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | Reagents Applications, Inc. | 1997-09-24 | 89 | 0 |
| K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | Reagents Applications, Inc. | 1992-07-30 | 44 | 0 |
| K915191 | RAI-TROL ELEVATED LIPIDS CONTROL | Reagents Applications, Inc. | 1991-12-18 | 29 | 0 |
| K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT | Reagents Applications, Inc. | 1991-09-25 | 57 | 0 |
| K911900 | RAICHEM SPIA C3 REAGENT | Reagents Applications, Inc. | 1991-05-09 | 13 | 0 |
| K911899 | RAICHEM SPIA C4 REAGENT | Reagents Applications, Inc. | 1991-05-09 | 13 | 0 |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | Reagents Applications, Inc. | 1991-05-08 | 12 | 0 |
| K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | Reagents Applications, Inc. | 1990-12-20 | 36 | 0 |
| K905085 | RAICHEM GGT REAGENT | Reagents Applications, Inc. | 1990-12-20 | 36 | 0 |
| K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Reagents Applications, Inc. | 1990-11-13 | 63 | 0 |
| K903123 | RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT | Reagents Applications, Inc. | 1990-09-14 | 60 | 0 |
| K902593 | RAICHEM(TM) SPIA(TM) CRP REAGENT | Reagents Applications, Inc. | 1990-06-28 | 16 | 0 |
| K900875 | RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT | Reagents Applications, Inc. | 1990-03-06 | 8 | 0 |
| K896845 | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | Reagents Applications, Inc. | 1990-02-16 | 72 | 0 |
| K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR | Reagents Applications, Inc. | 1990-01-25 | 45 | 0 |
| K896922 | RAICHEM TM HEMOGLOBIN REAGENT | Reagents Applications, Inc. | 1990-01-25 | 45 | 0 |
| K894418 | RAICHEM(TM) SPIA(TM) IGA REAGENTS | Reagents Applications, Inc. | 1989-08-02 | 16 | 0 |
| K894417 | RAICHEM(TM) SPIA(TM) IGM REAGENTS | Reagents Applications, Inc. | 1989-08-02 | 16 | 0 |
| K894416 | RAICHEM(TM) SPIA(TM) IGG REAGENTS | Reagents Applications, Inc. | 1989-08-01 | 15 | 0 |
| K883389 | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD | Reagents Applications, Inc. | 1988-12-14 | 126 | 0 |
| K882726 | RAICHEM(TM) BILIRUBIN STANDARD | Reagents Applications, Inc. | 1988-08-29 | 59 | 0 |
| K880576 | RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) | Reagents Applications, Inc. | 1988-06-10 | 121 | 0 |
| K880880 | RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC | Reagents Applications, Inc. | 1988-05-27 | 86 | 0 |
| K874822 | RAICHEM(TM) MAGNESIUM REAGENT | Reagents Applications, Inc. | 1988-01-21 | 58 | 0 |
| K874382 | RAICHEM(TM) ALCOHOL REAGENT | Reagents Applications, Inc. | 1988-01-11 | 77 | 0 |
| K872079 | RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS | Reagents Applications, Inc. | 1987-06-15 | 17 | 0 |
| K872080 | RAICHEM(TM) SPIA(TM) APO B REAGENTS | Reagents Applications, Inc. | 1987-06-15 | 17 | 0 |
| K870776 | RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT | Reagents Applications, Inc. | 1987-03-13 | 15 | 0 |
| K864819 | RAICHEM (TM)SERUM IRON AND TIBC REAGENTS | Reagents Applications, Inc. | 1987-02-12 | 65 | 0 |
| K864992 | RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) | Reagents Applications, Inc. | 1987-02-12 | 52 | 0 |
| K864706 | RAICHEM(TM) AMMONIA REAGENT | Reagents Applications, Inc. | 1987-01-05 | 34 | 0 |
| K863620 | RAICHEM(TM) CHLORIDE REAGENT | Reagents Applications, Inc. | 1986-09-26 | 10 | 0 |
| K862168 | RAICHEM CHOLINESTERASE REAGENT | Reagents Applications, Inc. | 1986-06-27 | 18 | 0 |
| K861269 | RAICHEM AMYLASE REAGENT | Reagents Applications, Inc. | 1986-05-29 | 55 | 0 |
| K861718 | AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 | Reagents Applications, Inc. | 1986-05-29 | 28 | 0 |
| K854544 | RAICHEM CO2 REAGENT | Reagents Applications, Inc. | 1985-12-13 | 30 | 0 |
| K854540 | RAICHEM/K.E | Reagents Applications, Inc. | 1985-11-26 | 13 | 0 |
| K844316 | RAICHEM PHOSPHORUS REAGENT | Reagents Applications, Inc. | 1985-01-03 | 48 | 0 |
| K843774 | RAICHEM X-HBDH REAGENT | Reagents Applications, Inc. | 1984-10-31 | 36 | 0 |
| K843353 | RAICHEM CALCIUM REAGENT | Reagents Applications, Inc. | 1984-09-20 | 24 | 0 |
| K842029 | TRIGLYCERIDES-GPO REAGENT | Reagents Applications, Inc. | 1984-07-09 | 52 | 0 |
| K841892 | RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT | Reagents Applications, Inc. | 1984-06-07 | 31 | 0 |
| K841466 | TOTAL PROTEIN REAGENT BIURET | Reagents Applications, Inc. | 1984-05-16 | 37 | 0 |
| K840872 | RAICHEM CREATININE REAGENT | Reagents Applications, Inc. | 1984-04-18 | 51 | 0 |
| K832463 | RAICHEM ALKALINE PHOSPHATASE REAGENT | Reagents Applications, Inc. | 1983-09-12 | 48 | 0 |
| K831834 | RAICHEM ACID PHASPHATASE REAGENT | Reagents Applications, Inc. | 1983-08-26 | 80 | 0 |
| K831419 | RAICHEM LDH-P REAGENT W/SEPARATE START- | Reagents Applications, Inc. | 1983-06-16 | 44 | 0 |
| K831585 | ALBUMIN REAGENT (BCG | Reagents Applications, Inc. | 1983-06-16 | 30 | 0 |
| K830207 | RAICHEM HDL-CHOLESTEROL REAGENT | Reagents Applications, Inc. | 1983-03-21 | 59 | 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