PREALBUMIN IMMUNOLOGICAL NL TEST KIT
FDA 510(k) clearance K913672 · decided 1991-12-20
Clearance details
- K-number
- K913672
- Device name
- PREALBUMIN IMMUNOLOGICAL NL TEST KIT
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-19
- Decision date
- 1991-12-20
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- JZJ
- Device class
- 1
- Regulation number
- 866.5060
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch The Binding Site
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| ANTISERUM TO HUMAN PREALBUMIN (K850686) | Kent Laboratories, Inc. | 1985-11-01 |
| 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.