Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALKALINE PHOSPHATASE (ALP)/PNPP

K-Number: K761315 · 1977-02-24

ApplicantPrinceton Biomedix
Decision Date1977-02-24
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE (ALP)/PNPP is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1977-02-24 under 510(k) number K761315. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE (ALP)/PNPP?

ALKALINE PHOSPHATASE (ALP)/PNPP is a medical device that received FDA 510(k) clearance on 1977-02-24. The listed applicant is Princeton Biomedix. The 510(k) number is K761315.

When did ALKALINE PHOSPHATASE (ALP)/PNPP receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE (ALP)/PNPP received FDA 510(k) clearance on 1977-02-24, under 510(k) number K761315.

Who is the listed applicant for ALKALINE PHOSPHATASE (ALP)/PNPP?

The FDA 510(k) record lists Princeton Biomedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALKALINE PHOSPHATASE (ALP)/PNPP?

The FDA product code for ALKALINE PHOSPHATASE (ALP)/PNPP is CJE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Princeton Biomedix as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942052LIFESIGN MI MYOGLOBINK925355BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TESTK930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPK925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TESTK926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TESTK901011BIOSIGN HCG-ONE STEP PREGNANCY TEST

View all 14 devices →

Related Devices (Code: CJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑