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510(k) K813261

RIAGEN PAP RIA by Biogenex Laboratories — Product Code JFH

K813261 is an FDA 510(k) premarket notification submitted by Biogenex Laboratories for the device "RIAGEN PAP RIA". The FDA issued a decision of Substantially Equivalent on December 17, 1981. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Biogenex Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1981
Date Received
November 20, 1981
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

Other clearances by Biogenex Laboratories

  • K012960 — BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (March 8, 2002)
  • K013148 — BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (February 28, 2002)
  • K925189 — PREGNAGEN 1-STEP PREGNANCY TEST (January 6, 1993)
  • K902208 — MODIFIED OVUGEN (July 17, 1990)
  • K884880 — PREGNAGEN(TM) (January 13, 1989)
  • K882002 — PREGNAGEN(TM) (September 9, 1988)
  • K873534 — OVUGEN SURETEST (November 23, 1987)
  • K831221 — RIAGEN B-HCG RIA KIT (June 2, 1983)
  • K821657 — RIAGEN B-HCG RIA (July 13, 1982)
  • K821234 — RIAGEN B-HCG RIA (May 21, 1982)

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)
  • K893508 — PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (August 4, 1989)

FDA data resources