FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAMMADAB LH RADIO-KIT #CA-1508
K Number: K823476
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
27
Review Days
36
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Basic Information
- Device Name
- GAMMADAB LH RADIO-KIT #CA-1508
- K Number
- K823476
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Assays, Inc.
- Date Received
- November 22, 1982
- Decision Date
- December 28, 1982
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Clinical Assays, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | Oct 4, 1983 | Substantially Equivalent |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Oct 4, 1983 | Substantially Equivalent |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | Oct 4, 1983 | Substantially Equivalent |
| K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST | Dec 22, 1982 | Substantially Equivalent |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | Jun 24, 1982 | Substantially Equivalent |
| K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT | Jun 22, 1982 | Substantially Equivalent |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Sep 24, 1981 | Substantially Equivalent |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | May 27, 1981 | Substantially Equivalent |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Apr 23, 1981 | Substantially Equivalent |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Oct 23, 1980 | Substantially Equivalent |