FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SRI TESTOSTERONE ENZYME IMMUNOASSAY
K Number: K915164
·
Decision Mar 2, 1992
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
23
Review Days
109
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Basic Information
- Device Name
- SRI TESTOSTERONE ENZYME IMMUNOASSAY
- K Number
- K915164
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serono-Baker Diagnostics, Inc.
- Date Received
- November 14, 1991
- Decision Date
- March 2, 1992
- Product Code
- CDZ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Serono-Baker Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY | Nov 30, 1992 | Substantially Equivalent |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | Mar 2, 1992 | Substantially Equivalent |
| K915602 | SRI DIGOXIN ENZYME IMMUNOASSAY | Jan 17, 1992 | Substantially Equivalent |
| K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY | Nov 19, 1991 | Substantially Equivalent |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | Oct 23, 1991 | Substantially Equivalent |
| K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | Sep 18, 1991 | Substantially Equivalent |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | Aug 16, 1991 | Substantially Equivalent |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | Jul 25, 1991 | Substantially Equivalent |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | May 28, 1991 | Substantially Equivalent |
| K910837 | SRI TSH IMMUNENZYMETRIC ASSAY | May 24, 1991 | Substantially Equivalent |