Home / 510(k) Clearances / K761315

510(k) K761315

ALKALINE PHOSPHATASE (ALP)/PNPP by Princeton Biomedix — Product Code CJE

K761315 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "ALKALINE PHOSPHATASE (ALP)/PNPP". The FDA issued a decision of Substantially Equivalent on February 24, 1977. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Princeton Biomedix has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1977
Date Received
December 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Princeton Biomedix

  • K942052 — LIFESIGN MI MYOGLOBIN (February 7, 1995)
  • K925355 — BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST (July 12, 1994)
  • K930185 — OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP (March 4, 1993)
  • K925183 — BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST (February 23, 1993)
  • K926308 — LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (January 26, 1993)
  • K901011 — BIOSIGN HCG-ONE STEP PREGNANCY TEST (May 4, 1990)
  • K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (October 18, 1989)
  • K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST (October 18, 1989)
  • K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (June 19, 1989)
  • K760345 — TEST, LACTATE DEHYDROGENASE (October 27, 1976)

Other clearances for product code CJE

  • K251074 — Tru Liver Health Test Panel (December 19, 2025)
  • K240468 — Alkaline Phosphatase (October 16, 2024)
  • K223317 — Alkaline Phosphatase2 (July 21, 2023)
  • K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin (August 30, 2019)
  • K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 (January 25, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 2017)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (August 15, 2013)
  • K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (March 22, 2013)
  • K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (July 12, 2012)

FDA data resources