HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
FDA 510(k) clearance K980770 · decided 1998-04-21
Clearance details
- K-number
- K980770
- Device name
- HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
- Applicant
- Diagnostic Chemicals , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-20
- Decision date
- 1998-04-21
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- LBR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Charlottetown, P.E.I., CA
- Third-party review
- No
- Expedited review
- No
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|---|
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| RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784) | Hemagen Diagnostics, Inc. | 2002-12-24 |
| VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593) | Ortho-Clinical Diagnostics, Inc. | 2001-08-30 |
| ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K992029) | Elan Diagnostics | 1999-08-12 |
| AUTOHDL CHOLESTEROL REAGENT SET (K992002) | Pointe Scientific, Inc., | 1999-08-05 |
| ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K991789) | Elan Holdings, Inc. | 1999-07-09 |
| MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247) | Polymer Technology Systems, Inc. | 1999-05-28 |
| VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303) | Ortho-Clinical Diagnostics, Inc. | 1999-01-28 |
| HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (K980772) | Diagnostic Chemicals , Ltd. | 1998-04-27 |
| BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL (K974733) | Boehringer Mannheim Corp. | 1998-01-26 |
Recalls involving this device
No recalls on record reference this clearance.