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510(k) K895723

IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) by Diagnostic Products Corp. — Product Code JFH

K895723 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
September 25, 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

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

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)
  • K893508 — PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (August 4, 1989)
  • K884748 — TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) (January 30, 1989)

FDA data resources