FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIA-GNOST PROGESTERONE
K Number: K890836
·
Decision Mar 16, 1989
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
14
Review Days
23
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Basic Information
- Device Name
- RIA-GNOST PROGESTERONE
- K Number
- K890836
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Medical Technology
- Date Received
- February 21, 1989
- Decision Date
- March 16, 1989
- Product Code
- JLS
- 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 |
|---|---|---|---|
| JLS | Radioimmunoassay, Progesterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLS), ordered by most recent decision date.
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
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ELECSYS PROGESTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VIDAS PROESTERONE (PRG) (30 409)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Cambridge Medical Technology
| K Number | Device Name | ||
|---|---|---|---|
| K890837 | RIA-GNOST INSULIN | Apr 26, 1989 | Substantially Equivalent |
| K890697 | RIA-GNOST FERRITIN | Mar 16, 1989 | Substantially Equivalent |
| K873737 | NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY | Nov 24, 1987 | Substantially Equivalent |
| K870573 | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT | Apr 22, 1987 | Substantially Equivalent |
| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | Aug 19, 1986 | Substantially Equivalent |
| K860130 | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT | Feb 19, 1986 | Substantially Equivalent |
| K855169 | T3 UPTAKE RADIOIMMUNOASSAY KIT | Feb 6, 1986 | Substantially Equivalent |
| K850254 | PARATHYROID HORMONE RADIOIMMUNOASSAY KIT | Apr 3, 1985 | Substantially Equivalent |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Sep 28, 1984 | Substantially Equivalent |
| K841042 | MATCHED COMPONENT SET RADIOIMMUNOASSAY | Apr 19, 1984 | Substantially Equivalent |