Home / 510(k) Clearances / K820005

510(k) K820005

TOTAL HEMOLYTIC COMPLEMENT TEST KIT by Meloy Laboratories, Inc.

K820005 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "TOTAL HEMOLYTIC COMPLEMENT TEST KIT". The FDA issued a decision of Substantially Equivalent on January 22, 1982. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
January 4, 1982
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)
  • K811178 — HUMAN IGG-ALBUMIN TEST KIT (May 15, 1981)
  • K792562 — IMMUNOSTAT TSH TEST (January 16, 1980)
  • K791493 — ANTI-NUCLEAR ANTIBODY TEST (September 24, 1979)
  • K791065 — IMMUNOSPOT TSH TEST (July 30, 1979)

FDA data resources