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510(k) K865014

LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II by Bio-Rad — Product Code DGR

K865014 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II". The FDA issued a decision of Substantially Equivalent on January 9, 1987. The device falls under product code DGR (Whole Human Serum, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5700. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1987
Date Received
December 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Human Serum, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5700
Review Panel
HE
Submission Type

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code DGR

  • K961544 — QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (September 24, 1996)
  • K902220 — PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (September 5, 1990)
  • K790298 — RADIOASSAY, CONTROL SERUM I, II, III (April 4, 1979)
  • K781355 — ICS NORMAL CONTROL SERUM (August 31, 1978)

FDA data resources