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510(k) K972812

RAICHEM PREALBUMIN SPIA by Hemagen Diagnostics, Inc. — Product Code DDS

K972812 is an FDA 510(k) premarket notification submitted by Hemagen Diagnostics, Inc. for the device "RAICHEM PREALBUMIN SPIA". The FDA issued a decision of Substantially Equivalent on August 28, 1997. The device falls under product code DDS (Prealbumin, Fitc, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5060. Hemagen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1997
Date Received
July 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prealbumin, Fitc, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5060
Review Panel
IM
Submission Type

Other clearances by Hemagen Diagnostics, Inc.

  • K041052 — RAICHEM GLUCOSE UV (LIQUID) (June 30, 2004)
  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (June 16, 2003)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K022772 — RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (September 17, 2002)
  • K022767 — RAICHEM LIPID CALIBRATOR (September 3, 2002)
  • K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (July 29, 2002)
  • K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT (July 19, 2002)
  • K012668 — RAICHEM GLUCOSE UV REAGENT (October 15, 2001)

Other clearances for product code DDS

  • K964781 — IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (May 9, 1997)
  • K934966 — SPQ PAL CONTROL LEVEL II (January 11, 1994)
  • K854811 — ICS PAB PREALBUMIN REAGENT TEST KIT (January 24, 1986)

FDA data resources