FDA 510(k)
Substantially Equivalent
🇺🇸 United States
IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST
K Number: K780709
·
Decision May 12, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
27
Review Days
16
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Basic Information
- Device Name
- IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST
- K Number
- K780709
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Clinical Assays, Inc.
- Date Received
- April 26, 1978
- Decision Date
- May 12, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- TX
- Third Party
- N
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 |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | Dec 28, 1982 | 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 |