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510(k) K864945

TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY by Hybritech, Inc. — Product Code JFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1987
Date Received
December 17, 1986
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 Hybritech, Inc.

  • K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (September 11, 1997)
  • K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (August 19, 1996)
  • K930810 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (January 11, 1994)
  • K922754 — TANDEM-E IGE II CALIBRATION VERIFICATION SET (February 17, 1993)
  • K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (July 30, 1992)
  • K920556 — TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (July 17, 1992)
  • K921252 — TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (July 17, 1992)
  • K921763 — TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (June 9, 1992)
  • K912439 — TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET (August 28, 1991)
  • K911417 — ICON STREP B IMMUNOENZYMETRIC ASSAY (July 24, 1991)

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)