Home / 510(k) Clearances / K771382

510(k) K771382

IMMUNOSTAT T3 UPTAKE TEST by Meloy Laboratories, Inc.

K771382 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "IMMUNOSTAT T3 UPTAKE TEST". The FDA issued a decision of Substantially Equivalent on September 2, 1977. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1977
Date Received
July 26, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Meloy Laboratories, Inc.

  • K852033 — SS-A(RO) & SS-B(LA) ANTIBODY ASSAY (June 21, 1985)
  • K844678 — MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL (January 4, 1985)
  • K841708 — MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII (July 19, 1984)
  • K842247 — MELOY AUTOANTIBODY TEST SYS (June 26, 1984)
  • K831292 — ANTI-ENA TEST (July 18, 1983)
  • K820265 — ANA TEST (MOUSE LIVER SUBSTRATE) (February 12, 1982)
  • K820005 — TOTAL HEMOLYTIC COMPLEMENT TEST KIT (January 22, 1982)
  • K811178 — HUMAN IGG-ALBUMIN TEST KIT (May 15, 1981)
  • K792562 — IMMUNOSTAT TSH TEST (January 16, 1980)
  • K791493 — ANTI-NUCLEAR ANTIBODY TEST (September 24, 1979)

FDA data resources