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510(k) K842328

AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN by Bartels Immunodiagnostic Supplies, Inc. — Product Code DEH

K842328 is an FDA 510(k) premarket notification submitted by Bartels Immunodiagnostic Supplies, Inc. for the device "AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN". The FDA issued a decision of Substantially Equivalent on August 3, 1984. The device falls under product code DEH (Lambda, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Bartels Immunodiagnostic Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1984
Date Received
June 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lambda, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
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)
  • K842833 — PMK PRIMARY MONKEY KIDNEY-CELLS (August 28, 1984)
  • K842329 — AMER. HISTO-ID SYS PRIMARY IGG S7920-11 (August 2, 1984)

Other clearances for product code DEH

  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • K140396 — FREELITE HUMAN LAMBDA FREE KIT (April 16, 2014)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (January 30, 2004)
  • K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETE (July 15, 2003)
  • K023131 — FREELITE HUMAN LAMBDA FREE KIT (January 21, 2003)
  • K010440 — FREELITE LAMBDA FREE KIT (April 26, 2001)
  • K010441 — FREELITE KAPPA FREE KIT (April 26, 2001)
  • K003671 — LAMBDA IMMAGE FREELITE KIT (February 1, 2001)
  • K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (October 26, 2000)

FDA data resources