Home / 510(k) Clearances / K842833

510(k) K842833

PMK PRIMARY MONKEY KIDNEY-CELLS by Bartels Immunodiagnostic Supplies, Inc. — Product Code KJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1984
Date Received
July 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Erythrosin B
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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)
  • K842834 — HEP-2 CELLS (August 28, 1984)
  • K842328 — AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (August 3, 1984)
  • K842327 — AMER. HISTO-ID SYS PRIMARY IGM S7920-31 (August 2, 1984)

Other clearances for product code KJR

  • K842834 — HEP-2 CELLS (August 28, 1984)
  • K792546 — FETAL CHECK (December 18, 1979)