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510(k) K811178

HUMAN IGG-ALBUMIN TEST KIT by Meloy Laboratories, Inc. — Product Code CJQ

K811178 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "HUMAN IGG-ALBUMIN TEST KIT". The FDA issued a decision of Substantially Equivalent on May 15, 1981. The device falls under product code CJQ (Radial Immunodiffusion, Albumin), a Class II device regulated under 21 CFR 862.1035. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
April 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radial Immunodiffusion, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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)
  • 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