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510(k) K810856

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT by Bartels Immunodiagnostic Supplies, Inc. — Product Code GPT

K810856 is an FDA 510(k) premarket notification submitted by Bartels Immunodiagnostic Supplies, Inc. for the device "DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code GPT (Antiserum, Cf, Psittacosis (Chlamydia Group)), a Class I device regulated under 21 CFR 866.3120. Bartels Immunodiagnostic Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
March 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Psittacosis (Chlamydia Group)
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Bartels Immunodiagnostic Supplies, Inc.

  • K864776 — A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS (December 31, 1986)
  • K861172 — ROTAVIRUS LATEX AGGLUTINATION ASSAY (July 1, 1986)
  • K860279 — CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT (May 13, 1986)
  • K855034 — AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT (March 11, 1986)
  • K842830 — IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (November 26, 1985)
  • K852185 — RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT (August 19, 1985)
  • K844105 — FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY (December 6, 1984)
  • K842833 — PMK PRIMARY MONKEY KIDNEY-CELLS (August 28, 1984)
  • K842834 — HEP-2 CELLS (August 28, 1984)
  • K842328 — AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (August 3, 1984)

FDA data resources