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510(k) K952817

BIO-RAD URINARY 5-HIAA BY HPLC by Bio-Rad — Product Code CDA

K952817 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BIO-RAD URINARY 5-HIAA BY HPLC". The FDA issued a decision of Substantially Equivalent on August 1, 1995. The device falls under product code CDA (Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin), a Class I device regulated under 21 CFR 862.1390. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1995
Date Received
June 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Device Class
Class I
Regulation Number
862.1390
Review Panel
CH
Submission Type

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  • 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 CDA

  • K903609 — SEROTONIN ENZYME IMMUNOASSAY (October 22, 1990)
  • K854946 — TDXR 5-HIAA (URINE) (January 17, 1986)

FDA data resources