FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELISA TUBE PROLACTIN TEST KIT
K Number: K920921
·
Decision Apr 8, 1992
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
14
Review Days
40
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Basic Information
- Device Name
- ELISA TUBE PROLACTIN TEST KIT
- K Number
- K920921
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio Clinic Co.
- Date Received
- February 28, 1992
- Decision Date
- April 8, 1992
- 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 Bio Clinic Co.
| K Number | Device Name | ||
|---|---|---|---|
| K930791 | AMERICAN POWER CONVERSIONS, BACK-UPS 600 | Aug 6, 1993 | Substantially Equivalent |
| K932480 | PRISM | Jul 21, 1993 | Substantially Equivalent |
| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Jun 24, 1993 | Substantially Equivalent |
| K921958 | ELISA TUBE TSH TEST | Jul 2, 1992 | Substantially Equivalent |
| K922140 | ORTHODERM CONVERTIBLE II | May 27, 1992 | Substantially Equivalent |
| K921212 | MIRCO ELISA HPL TEST KIT | May 7, 1992 | Substantially Equivalent |
| K921211 | NOW PREGNANCY TEST KIT | May 7, 1992 | Substantially Equivalent |
| K920920 | ELISA TUBE LH TEST KIT | Apr 8, 1992 | Substantially Equivalent |
| K920918 | TMB CHROMOGEN/SUBSTRATE REAGENT SET | Apr 7, 1992 | Substantially Equivalent |
| K920917 | ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY | Mar 26, 1992 | Substantially Equivalent |