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510(k) K792640

FLUOROMATIC PHENYTOIN FIA by Bio-Rad — Product Code DLP

K792640 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "FLUOROMATIC PHENYTOIN FIA". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code DLP (Radioimmunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
December 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
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 DLP

  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K811775 — KALLESTAD ANTISERA TO PHENYTOIN (July 10, 1981)
  • K791896 — CENTRIA PHENYTOIN RIA TEST SET (October 17, 1979)
  • K770779 — PHENYTOIN RIA KIT (June 17, 1977)

FDA data resources