UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
FDA 510(k) clearance K974721 · decided 1998-03-03
Clearance details
- K-number
- K974721
- Device name
- UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- Applicant
- Bayer Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-18
- Decision date
- 1998-03-03
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- CGI
- Device class
- 1
- Regulation number
- 862.1265
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bayer Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (K962875) | Diagnostic Systems Laboratories, Inc. | 1996-08-23 |
| ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (K955356) | Diagnostic Systems Laboratories, Inc. | 1996-05-15 |
| COAT-A-COUNT FREE ESTRIOL (K932989) | Diagnostic Products Corp. | 1994-12-19 |
| AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT (K944490) | Wallac OY | 1994-12-09 |
| AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL (K920576) | Eastman Kodak Company | 1992-03-23 |
| MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (K903359) | Immunotech Corp. | 1990-08-22 |
| IMMPULSE FREE ESTRIOL ASSAY REAGENTS (K860900) | Sclavo, Inc. | 1986-04-28 |
| SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (K850787) | Nms Pharmaceuticals, Inc. | 1985-03-26 |
| RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (K844767) | Biotecx Laboratories, Inc. | 1985-02-01 |
| TDX TOTAL ESTRIOL (K844511) | Abbott Laboratories | 1985-01-18 |
| AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED (K844408) | Amersham Corp. | 1984-12-11 |
| ENDAB ESTRIOL UNCONJUGATED (K840902) | Immunotech Corp. | 1984-04-18 |
Recalls involving this device
No recalls on record reference this clearance.