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510(k) K771585

T3 UPTAKE DIAG. KIT by Antibodies, Inc.

K771585 is an FDA 510(k) premarket notification submitted by Antibodies, Inc. for the device "T3 UPTAKE DIAG. KIT". The FDA issued a decision of Substantially Equivalent on September 13, 1977. Antibodies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1977
Date Received
August 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Antibodies, Inc.

  • K890774 — GIARDEIA(TM) (April 4, 1989)
  • K843590 — DETECT-A-STREP (October 30, 1984)
  • K822892 — CORTISOL RIA KIT (November 1, 1982)
  • K812749 — ULTRA-DIG (October 19, 1981)
  • K812314 — CRITHIDNA ANTI-DNA TEST KIT (September 1, 1981)
  • K802877 — AMIKACIN RIA KIT (December 19, 1980)
  • K800743 — TOBRAMYCIN RIA KIT (April 16, 1980)
  • K791217 — TSH RIA KIT (September 4, 1979)
  • K781654 — NEPHELRATE ANTIPERUMS LGM (November 8, 1978)
  • K781656 — NEPHELRATE ANTISERUMS, IGG (November 8, 1978)

FDA data resources