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510(k) K893508

PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI by Baxter Healthcare Corp — Product Code JFH

K893508 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI". The FDA issued a decision of Substantially Equivalent on August 4, 1989. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1989
Date Received
May 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase (Prostatic), Tartrate Inhibited
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

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  • K130531 — ULTRAFUSE (April 8, 2014)
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  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

Other clearances for product code JFH

  • K000257 — IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 (February 23, 2000)
  • K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (September 15, 1998)
  • K964756 — PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT (April 23, 1997)
  • K931701 — IMMULITE PAP (January 27, 1994)
  • K925377 — IMX PAP (January 13, 1993)
  • K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (July 30, 1992)
  • K902937 — MILENIA PAP IRMA CATALOG #: MKPA1, X (September 21, 1990)
  • K901933 — COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 (June 28, 1990)
  • K895723 — IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) (October 31, 1989)
  • K884748 — TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) (January 30, 1989)

FDA data resources