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510(k) K901805

REP(R) IMMUNOFIX by Helena Laboratories — Product Code DAH

K901805 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "REP(R) IMMUNOFIX". The FDA issued a decision of Substantially Equivalent on June 6, 1990. The device falls under product code DAH (Gamma Globulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1990
Date Received
April 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gamma Globulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

Other clearances for product code DAH

  • K931247 — TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (April 27, 1993)
  • K905149 — TITAN GEL (January 3, 1991)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K883494 — TECHNICON DPA-1 IMMUNOGLOBULIN G (September 7, 1988)
  • K854944 — TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT (August 27, 1986)
  • K862184 — DAKO ITA, IMMUNOGLOBULIN M (IGM) (August 19, 1986)

FDA data resources