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510(k) K852033

SS-A(RO) & SS-B(LA) ANTIBODY ASSAY by Meloy Laboratories, Inc. — Product Code DHN

K852033 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "SS-A(RO) & SS-B(LA) ANTIBODY ASSAY". The FDA issued a decision of Substantially Equivalent on June 21, 1985. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1985
Date Received
May 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Meloy Laboratories, Inc.

  • 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)
  • K791065 — IMMUNOSPOT TSH TEST (July 30, 1979)

Other clearances for product code DHN

  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K172745 — ImmuGlo HEp-2 Elite IFA (June 5, 2018)
  • K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (July 28, 2016)
  • K160265 — Image Navigator by Immuno Concepts (June 17, 2016)
  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)
  • K150155 — NOVA Lite DAPI ANA Kit (April 8, 2015)
  • K131791 — IFA 40: HEP-20-10 (February 26, 2014)
  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)

FDA data resources