510(k) K955356
- Device
- ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
- Applicant
- DIAGNOSTIC SYSTEMS LABORATORIES, INC.
- 510(k) number
- K955356
- Product code
- CGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-15
- Date received
- 1995-11-21
- Regulation
- 862.1265
- Classification name
- Radioimmunoassay, Estriol
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN WILLIS
- Address
- 445 Medical Center Blvd. Webster TX US 77598 77598
FDA Registration Numbers#
- 1036362
- 3002800697
- 3005542422
- 3008198807
- 2020726
- 1222302
- 2432235
- 2029372
- 2133982
- 2245285
- 3006198300
- 3022178699
- 3009984016
- 3002806944
- 8043909
- 3007118747
- 2122870
- 8010132
Source Documents#
Other 510(k) Records For Product Code CGI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974721 | UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1998-03-03 |
| K962875 | ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-23 |
| K932989 | COAT-A-COUNT FREE ESTRIOL | Diagnostic Products Corp. | 1994-12-19 |
| K944490 | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | Wallac OY | 1994-12-09 |
| K920576 | AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL | Eastman Kodak Company | 1992-03-23 |
| K903359 | MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT | Immunotech Corp. | 1990-08-22 |
| K860900 | IMMPULSE FREE ESTRIOL ASSAY REAGENTS | Sclavo, Inc. | 1986-04-28 |
| K850787 | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY | Nms Pharmaceuticals, Inc. | 1985-03-26 |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | Biotecx Laboratories, Inc. | 1985-02-01 |
| K844511 | TDX TOTAL ESTRIOL | Abbott Laboratories | 1985-01-18 |
| K844408 | AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED | Amersham Corp. | 1984-12-11 |
| K840902 | ENDAB ESTRIOL UNCONJUGATED | Immunotech Corp. | 1984-04-18 |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | New England Nuclear | 1984-03-30 |
| K830816 | DSL 1900 | Diagnostic Systems | 1983-04-12 |
| K823202 | FREE & TOTAL ESTRIOL KIT | Diagnostic Products Corp. | 1982-12-15 |
Legacy Summary#
summary
FDA Review#
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