Home / 510(k) Clearances / K932679

510(k) K932679

RHEUMELISA II HISTONE ANTIBODY TEST KIT by Biowhittaker Molecular Applications, Inc. — Product Code LKJ

K932679 is an FDA 510(k) premarket notification submitted by Biowhittaker Molecular Applications, Inc. for the device "RHEUMELISA II HISTONE ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on August 23, 1993. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Biowhittaker Molecular Applications, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1993
Date Received
June 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Biowhittaker Molecular Applications, Inc.

  • K943843 — VARICELISA, MODIFICATION (March 14, 1996)
  • K942250 — BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER (April 4, 1995)
  • K942361 — WHITSOFT (April 4, 1995)
  • K942245 — BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (April 3, 1995)
  • K925209 — MUMPS STAT (October 14, 1994)
  • K935618 — SPECIMEN TRANSPORT MEDIUM (April 21, 1994)
  • K930757 — RHEUMELISA II JO-1 ANTIBODY TEST KIT (March 26, 1993)
  • K930130 — RHEUMELISA II SCL-70 ANTIBODY TEST KIT (March 23, 1993)
  • K920753 — RF STAT IGM TEST KIT (March 30, 1992)

Other clearances for product code LKJ

  • K210902 — EliA Ro52, EliA Ro60 (July 27, 2022)
  • K113610 — ANA-SCREEN WITH MDSS (July 9, 2012)
  • K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMU (April 10, 2009)
  • K081104 — AESKULISA ANA HEP-2, REF 30-7115US (May 2, 2008)
  • K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL (December 20, 2004)
  • K042416 — ATHENA MULTI-LYTE ANA-II TEST SYSTEM (October 8, 2004)
  • K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (January 8, 2004)
  • K030775 — AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (May 12, 2003)
  • K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (January 17, 2003)
  • K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (January 17, 2003)

FDA data resources