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510(k) K771155

ANTI-MITOCHONDRIAL by Meloy Laboratories, Inc. — Product Code DBE

K771155 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "ANTI-MITOCHONDRIAL". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code DBE (Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5120. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1977
Date Received
June 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5120
Review Panel
IM
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)
  • K811178 — HUMAN IGG-ALBUMIN TEST KIT (May 15, 1981)
  • K792562 — IMMUNOSTAT TSH TEST (January 16, 1980)
  • K791493 — ANTI-NUCLEAR ANTIBODY TEST (September 24, 1979)

Other clearances for product code DBE

  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)
  • K800820 — AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY (April 24, 1980)
  • K800228 — IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT (February 21, 1980)
  • K790430 — MEDICA II-F-ASMA TEST KIT (April 23, 1979)
  • K760156 — TEST, (IVDP) SMOOTHMUSCLE ANTIBODY (July 20, 1976)

FDA data resources