FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
K Number: K895380
·
Decision Oct 17, 1989
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
23
Review Days
48
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Basic Information
- Device Name
- SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
- K Number
- K895380
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono-Baker Diagnostics, Inc.
- Date Received
- August 30, 1989
- Decision Date
- October 17, 1989
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFT), ordered by most recent decision date.
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
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SEALITE SCIENCES, INC. AQUALITE PROLACTIN
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DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
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DSL ACTIVE PROLACTIN IRMA
FDA 510(k)
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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 |
| 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 |