FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K Number: K873400
·
Decision Sep 25, 1987
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
25
Review Days
32
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
- PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
- K Number
- K873400
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono Diagnostics, Inc.
- Date Received
- August 24, 1987
- Decision Date
- September 25, 1987
- 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 Serono Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | Mar 11, 1996 | Substantially Equivalent |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Jul 13, 1994 | Substantially Equivalent |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | Sep 9, 1988 | Substantially Equivalent |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | Aug 8, 1988 | Substantially Equivalent |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | Mar 3, 1988 | Substantially Equivalent |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | Feb 11, 1988 | Substantially Equivalent |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Oct 20, 1987 | Substantially Equivalent |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | Sep 29, 1987 | Substantially Equivalent |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | Sep 18, 1987 | Substantially Equivalent |
| K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE | Sep 14, 1987 | Substantially Equivalent |