FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRL QUIK RIA KIT
K Number: K850383
·
Decision Mar 1, 1985
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
29
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PRL QUIK RIA KIT
- K Number
- K850383
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pacific Biotech, Inc.
- Date Received
- February 1, 1985
- Decision Date
- March 1, 1985
- 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
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS PROLACTIN ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL ACTIVE PROLACTIN IRMA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Pacific Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924461 | STREP A NEGATIVE CONTROL | Dec 2, 1993 | Substantially Equivalent |
| K902510 | CARDS O.S. MONO | Jul 16, 1990 | Substantially Equivalent |
| K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT | Mar 6, 1990 | Substantially Equivalent |
| K896221 | CARDS O.S.(TM) STREP A | Dec 13, 1989 | Substantially Equivalent |
| K895390 | CARDS O.S. (TM) HCG-URINE | Nov 13, 1989 | Substantially Equivalent |
| K891770 | HCG IRMA II | May 24, 1989 | Substantially Equivalent |
| K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II | Jan 13, 1989 | Substantially Equivalent |
| K883742 | MODIFIED TSH IRMA KIT | Jan 3, 1989 | Substantially Equivalent |
| K884007 | CARDS(TM) MONO | Nov 18, 1988 | Substantially Equivalent |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | Oct 12, 1988 | Substantially Equivalent |