FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SR1 FREE T4 ENZYME IMMUNOASSAY
K Number: K912937
·
Decision Nov 19, 1991
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
23
Review Days
137
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Basic Information
- Device Name
- SR1 FREE T4 ENZYME IMMUNOASSAY
- K Number
- K912937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serono-Baker Diagnostics, Inc.
- Date Received
- July 5, 1991
- Decision Date
- November 19, 1991
- Product Code
- CEC
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | 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 |
| K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY | Mar 2, 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 |
| 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 |