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510(k) K780709

IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST by Clinical Assays, Inc.

K780709 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST". The FDA issued a decision of Substantially Equivalent on May 12, 1978. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K832710 — VITAMIN B12 RADIOASSAY KIT CA-1534 (October 4, 1983)
  • K832712 — FOLATE RADIOASSAY KIT CA-1562-125 (October 4, 1983)
  • K832711 — VITAMIN B12 FOLATE CA-1515-125 (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)

FDA data resources