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510(k) K792043

PAP-CHECK RIA KIT by Serono Laboratories, Inc. — Product Code JFH

K792043 is an FDA 510(k) premarket notification submitted by Serono Laboratories, Inc. for the device "PAP-CHECK RIA KIT". The FDA issued a decision of Substantially Equivalent on October 30, 1979. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Serono Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1979
Date Received
October 12, 1979
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 Serono Laboratories, Inc.

  • K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (March 2, 1984)
  • K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT (March 31, 1981)
  • K810625 — HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- (March 27, 1981)
  • K790679 — ESTRADIOL RIA KIT (May 23, 1979)
  • K790440 — PROGESTERONE (May 3, 1979)
  • K782143 — RIA KIT, GLUCOSE (February 22, 1979)
  • K782103 — RIA KIT, NEONATAL T4 (January 17, 1979)
  • K781733 — RIA KIT, PREG-STAT (December 20, 1978)
  • K781285 — INSULIN RIA KIT (August 14, 1978)

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