FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPUS(R) PROLACTIN TEST SYSTEM
K Number: K913280
·
Decision Aug 16, 1991
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
35
Review Days
23
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Basic Information
- Device Name
- OPUS(R) PROLACTIN TEST SYSTEM
- K Number
- K913280
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pb Diagnostic Systems, Inc.
- Date Received
- July 24, 1991
- Decision Date
- August 16, 1991
- Product Code
- CFT
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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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ELECSYS PROLACTIN ASSAY
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DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
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FDA Class 1
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DSL ACTIVE PROLACTIN IRMA
FDA 510(k)
FDA Class 1
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Other Clearances by Pb Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940507 | OPUS FT4 TEST SYSTEM | Jul 28, 1994 | Substantially Equivalent |
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | Jul 20, 1994 | Substantially Equivalent |
| K933389 | OPUS CMV-G | Jun 28, 1994 | Substantially Equivalent |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Mar 7, 1994 | Substantially Equivalent |
| K935229 | OPUS DIGITOXIN | Dec 22, 1993 | Substantially Equivalent |
| K934705 | OPUS NAPA | Nov 22, 1993 | Substantially Equivalent |
| K933675 | OPUS TOTAL CK | Sep 8, 1993 | Substantially Equivalent |
| K933066 | OPUS ESTRADIOL | Sep 8, 1993 | Substantially Equivalent |
| K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM | Jul 8, 1993 | Substantially Equivalent |
| K926131 | OPUS MAGNUM ANALYZER | Jun 7, 1993 | Substantially Equivalent |