510(k) K934801
- Device
- Spinpro Hdl Precipitating Reagent
- Applicant
- MERCHANT HOUSE SCIENTIFIC
- 510(k) number
- K934801
- Product code
- LBR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-12-07
- Date received
- 1993-10-07
- Regulation
- 862.1475
- Classification name
- Ldl & Vldl Precipitation, Hdl
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER C FEISTEL
- Address
- 1370 Reynolds Ave., Suite 119 Irvine CA US 92714 92714
FDA Registration Numbers#
- 3013660430
- 8020316
- 3012133212
- 3003539867
- 3003522182
- 3005333358
- 1319809
- 3012963943
- 3020885868
- 2250051
- 1832216
- 1319808
- 3003419906
- 1649661
- 3004146366
- 3015525148
- 3008959428
- 9613069
- 3011061417
- 3021010433
- 3002736372
- 1827821
- 3004111573
- 9615507
- 3003593973
- 3002642396
- 3010891909
- 2032900
- 2531491
- 2085064
- 1616487
- 9610126
- 2030633
- 1319681
- 3023162659
- 1219029
- 3021841051
- 3000308930
- 3000148879
Source Documents#
510(k) summary PDF not indicated by FDA
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| K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 | Diagnostic Chemicals , Ltd. | 1998-04-27 |
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| K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL | Boehringer Mannheim Corp. | 1998-01-26 |
| K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | Roche Diagnostic Systems, Inc. | 1997-11-21 |
| K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | 1997-06-18 |