510(k) K924659
- Device
- Olyumpus Total Protein Reagent
- Applicant
- OLYMPUS CORP.
- 510(k) number
- K924659
- Product code
- CEK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-29
- Date received
- 1992-09-15
- Regulation
- 862.1635
- Classification name
- Biuret (Colorimetric), Total Protein
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA STORMS-TYLER
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 3013660430
- 3005094123
- 3006198300
- 8020316
- 1063851
- 3003795116
- 2030861
- 1181121
- 9680746
- 2050012
- 3005333358
- 3003741796
- 9610529
- 2432235
- 1319809
- 2250051
- 1832216
- 8040374
- 2020715
- 3002809144
- 1036362
- 2517506
- 2247288
- 3007662974
- 1827821
- 3011989923
- 3004493545
- 2939693
- 3008517993
- 3016438761
- 3003593973
- 2050010
- 3010825766
- 1616487
- 3014325803
- 9610126
- 1220972
- 1319681
- 3021841051
- 3006716639
- 3000148879
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CEK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992846 | HICHEM TOTAL PROTEIN REAGENT | Elan Holdings, Inc. | 1999-10-18 |
| K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | Diagnostic Chemicals , Ltd. | 1998-03-02 |
| K980042 | CARESIDE TOTAL PROTEIN | Exigent Diagnostics, Inc. | 1998-02-04 |
| K971524 | TOTAL PROTEIN OR TP | Carolina Liquid Chemistries Corp. | 1997-05-16 |
| K961864 | CSF/URINE TOTAL PROTEIN | Teco Diagnostics | 1996-10-24 |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | Solarcare Technologies Corp,Inc. | 1996-05-30 |
| K955936 | TOTAL PROTEIN REAGENT | Derma Media Lab., Inc. | 1996-03-12 |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Dupont Medical Products | 1995-08-11 |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-06-14 |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-05-15 |
| K943004 | TOTAL PROTEIN QVET | Prisma Systems | 1994-12-09 |
| K941496 | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY | Solarcare, Inc. | 1994-10-27 |
| K942424 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1994-09-06 |
| K934841 | URINARY/CEREBROSPINAL FLUID PROTEIN | E.I. Dupont DE Nemours & Co., Inc. | 1994-04-06 |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Em Diagnostic Systems, Inc. | 1993-12-16 |