ANTISERUM TO HUMAN PREALBUMIN
FDA 510(k) clearance K850686 · decided 1985-11-01
Clearance details
- K-number
- K850686
- Device name
- ANTISERUM TO HUMAN PREALBUMIN
- Applicant
- Kent Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-21
- Decision date
- 1985-11-01
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- JZJ
- Device class
- 1
- Regulation number
- 866.5060
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RANDOX PREALBUMIN (K000661) | Randox Laboratories, Ltd. | 2000-04-13 |
| TINA-QUANT PREALBUMIN (K972638) | Boehringer Mannheim Corp. | 1998-01-09 |
| HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (K951966) | Kent Laboratories, Inc. | 1995-06-01 |
| PREALBUMIN IMMUNOLOGICAL NL TEST KIT (K913672) | The Binding Site, Ltd. | 1991-12-20 |
| SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (K884298) | Atlantic Antibodies | 1988-11-02 |
| SPQ(TM) TEST SYSTEM FOR PREALBUMIN (K884297) | Atlantic Antibodies | 1988-11-02 |
| QM300 PREALBUMIN ANTIBODY PACK (K883002) | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 |
| LASER PREALBUMIN TEST (K851912) | Behring Diagnostics, Inc. | 1985-06-21 |
| PREALBUMIN ENZYME IMMUNOASSAY (K821135) | Abbott Laboratories | 1983-05-05 |
| LAS-R HUMAN PREALBUMIN TEST (K772329) | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 |
Recalls involving this device
No recalls on record reference this clearance.