Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CEK — Predicate Candidate Screening
116 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
153 days90th percentile
116clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992846 | HICHEM TOTAL PROTEIN REAGENT | Elan Holdings, Inc. | 1999-10-18 | 55 | 0 |
| K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | Diagnostic Chemicals , Ltd. | 1998-03-02 | 195 | 0 |
| K980042 | CARESIDE TOTAL PROTEIN | Exigent Diagnostics, Inc. | 1998-02-04 | 29 | 0 |
| K971524 | TOTAL PROTEIN OR TP | Carolina Liquid Chemistries Corp. | 1997-05-16 | 18 | 0 |
| K961864 | CSF/URINE TOTAL PROTEIN | Teco Diagnostics | 1996-10-24 | 163 | 0 |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | Solarcare Technologies Corp,Inc. | 1996-05-30 | 153 | 0 |
| K955936 | TOTAL PROTEIN REAGENT | Derma Media Lab., Inc. | 1996-03-12 | 82 | 0 |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Dupont Medical Products | 1995-08-11 | 163 | 0 |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-06-14 | 152 | 0 |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-05-15 | 123 | 0 |
| K943004 | TOTAL PROTEIN QVET | Prisma Systems | 1994-12-09 | 169 | 0 |
| K941496 | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY | Solarcare, Inc. | 1994-10-27 | 213 | 0 |
| K942424 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1994-09-06 | 109 | 0 |
| K934841 | URINARY/CEREBROSPINAL FLUID PROTEIN | E.I. Dupont DE Nemours & Co., Inc. | 1994-04-06 | 180 | 0 |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Em Diagnostic Systems, Inc. | 1993-12-16 | 50 | 0 |
| K921412 | MICROPROTEIN REAGENT SET | Sterling Diagnostics, Inc. | 1993-01-21 | 303 | 0 |
| K924659 | OLYUMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | 1992-12-29 | 105 | 0 |
| K922467 | SYNCHRON TOTAL PROTEIN TEST --MODIFIED | Beckman Instruments, Inc. | 1992-11-23 | 193 | 0 |
| K923267 | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 | 69 | 0 |
| K923266 | NOVA TOTAL PROTEIN MODULE | Nova Biomedical Corp. | 1992-08-12 | 41 | 0 |
| K922361 | OLYMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | 1992-07-16 | 58 | 0 |
| K920531 | WAKO AUTOKIT MICRO TP | Wako Chemicals USA, Inc. | 1992-07-14 | 160 | 0 |
| K915380 | MICROPROTEIN-PR | Sigma Diagnostics, Inc. | 1992-02-18 | 81 | 0 |
| K914885 | BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST | Beckman Instruments, Inc. | 1992-01-30 | 92 | 0 |
| K913225 | URINE/CSF MICROPROTEIN REAGENT | Intersect Systems, Inc. | 1991-10-11 | 84 | 0 |
| K913978 | TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE | Beckman Instruments, Inc. | 1991-10-09 | 33 | 0 |
| K912810 | ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 | Em Diagnostic Systems, Inc. | 1991-07-30 | 35 | 0 |
| K905790 | TOTAL PROTEIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-21 | 56 | 0 |
| K905661 | SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 | Em Diagnostic Systems, Inc. | 1991-01-31 | 44 | 0 |
| K904603 | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM | Quantitative Medicine, Inc. | 1991-01-25 | 107 | 0 |
| K903511 | SYNERMED TOTAL PROTEIN REAGENT KIT | Synermed, Inc. | 1990-09-07 | 35 | 0 |
| K901527 | BIURET (COLORMETRIC), TOTAL PROTEIN | American Research Products Co. | 1990-07-19 | 108 | 0 |
| K900733 | PROTEIN TEST FOR URINE AND CSF | Elite Technology, Inc. | 1990-07-10 | 144 | 0 |
| K897166 | COULTER TOTAL PROTEIN REAGENT | Coulter Electronics, Inc. | 1990-02-23 | 57 | 0 |
| K896230 | COBAS READY TOTAL PROTEIN REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | 109 | 0 |
| K896916 | CLINISTAT TOTAL PROTEIN REAGENT TEST | Heraeus Kulzer, Inc. | 1990-01-19 | 39 | 0 |
| K893915 | EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 | Em Diagnostic Systems, Inc. | 1989-08-31 | 93 | 0 |
| K890618 | COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT | Kenlor Industries, Inc. | 1989-05-22 | 104 | 0 |
| K890868 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1989-03-20 | 27 | 0 |
| K890278 | TOTAL PROTEIN REAGENT | Sigma Chemical Co. | 1989-03-09 | 50 | 0 |
| K890317 | TOTAL PROTEIN REAGENT | Medical Analysis Systems, Inc. | 1989-03-08 | 44 | 0 |
| K884703 | TOTAL PROTEIN TEST (TP) ITEM #65670 | Em Diagnostic Systems, Inc. | 1989-01-23 | 75 | 0 |
| K884225 | TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS | A-Kem, Inc. | 1988-12-09 | 64 | 0 |
| K881639 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) | Eastman Kodak Company | 1988-07-08 | 85 | 0 |
| K882189 | BIOTROL TOTAL PROTEIN H.P. | Biotrol, USA, Inc. | 1988-07-01 | 38 | 0 |
| K880312 | WAKO(TM) AUTOKIT TOTAL PROTEIN | Wako Chemicals USA, Inc. | 1988-03-24 | 59 | 0 |
| K880677 | TOTAL PROTEIN REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-24 | 34 | 0 |
| K875222 | TOTAL PROTEIN | Catachem, Inc. | 1988-01-22 | 31 | 0 |
| K874476 | EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 | Em Diagnostic Systems, Inc. | 1987-11-25 | 23 | 0 |
| K870371 | TOTAL PROTEIN REAGENT - BIURET METHOD | Trace Scientific , Ltd. | 1987-08-19 | 203 | 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