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510(k) K831927

ANTINUCLEAR ANTIBODY TEST KIT by Breit Laboratories, Inc. — Product Code DAA

K831927 is an FDA 510(k) premarket notification submitted by Breit Laboratories, Inc. for the device "ANTINUCLEAR ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code DAA (Igg, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Breit Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
June 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
PA
Submission Type

Other clearances by Breit Laboratories, Inc.

  • K851099 — IGM RHEUMATOID FACTOR TEST KIT (April 25, 1985)
  • K842137 — OCCULT BLOOD TEST (September 5, 1984)
  • K840527 — COLOTRAK OCCULT BLOOD TEST (September 5, 1984)
  • K832031 — ANTI-N DNA ANTIBODY TEST KIT (August 11, 1983)

Other clearances for product code DAA

  • K832675 — ANA MICROZYME TEST SYS #1610 (September 12, 1983)
  • K830005 — IP SPECIFIC G (June 2, 1983)
  • K822911 — ANAZYME ANA PEROXIDASE TEST SYSTEM (October 22, 1982)
  • K791749 — INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL (October 17, 1979)

FDA data resources