FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
510(k) Clearances
/ K780709
510(k) K780709
IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST by
Clinical Assays, Inc.
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1978
Date Received
April 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances by Clinical Assays, Inc.
K832712
— FOLATE RADIOASSAY KIT CA-1562-125 (October 4, 1983)
K832711
— VITAMIN B12 FOLATE CA-1515-125 (October 4, 1983)
K832710
— VITAMIN B12 RADIOASSAY KIT CA-1534 (October 4, 1983)
K823476
— GAMMADAB LH RADIO-KIT #CA-1508 (December 28, 1982)
K823313
— IN VITRO GAMMACOAT B-HCG RADIO. TEST (December 22, 1982)
K821611
— GAMMADAB [125] FSH RADIOIMMUNAY KIT (June 24, 1982)
K821092
— GAMMADAB[125]EGE RADIOIMMUNOASSAY IT (June 22, 1982)
K812227
— GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY (September 24, 1981)
K810722
— GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)
K810967
— IN-VITRO TBG RADIOIMMUNOASSAY TEST (April 23, 1981)