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510(k) K911898

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT by Reagents Applications, Inc. — Product Code DAD

K911898 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT". The FDA issued a decision of Substantially Equivalent on May 8, 1991. The device falls under product code DAD (Haptoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5460. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1991
Date Received
April 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Haptoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5460
Review Panel
IM
Submission Type

Other clearances by Reagents Applications, Inc.

  • K982056 — RAICHEM CO2 REAGENT (June 24, 1998)
  • K972853 — CHOLESTEROL RAPID LIQUID REAGENT (September 24, 1997)
  • K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II (July 30, 1992)
  • K915191 — RAI-TROL ELEVATED LIPIDS CONTROL (December 18, 1991)
  • K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT (September 25, 1991)
  • K911899 — RAICHEM SPIA C4 REAGENT (May 9, 1991)
  • K911900 — RAICHEM SPIA C3 REAGENT (May 9, 1991)
  • K905084 — RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV (December 20, 1990)
  • K905085 — RAICHEM GGT REAGENT (December 20, 1990)
  • K904175 — RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (November 13, 1990)

Other clearances for product code DAD

  • K993480 — K-ASSAY HAPTOGLOBIN (November 24, 1999)
  • K972639 — TINA-QUANT HAPTOGLOBIN (January 9, 1998)
  • K964301 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (October 7, 1996)
  • K952593 — N/T PROTEIN CONTROL SY/L, M AND H (July 17, 1995)
  • K915829 — IL TEST(TM) HAPTOGLOBIN (HPT) (July 29, 1992)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K873866 — HAPTOGLOBIN (October 20, 1987)
  • K872717 — QM300 HAPTOGLOBIN ANTIBODY PACK (July 21, 1987)
  • K864512 — IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (February 13, 1987)

FDA data resources