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)

PHADEBAS ISOAMYLASE TEST

K-Number: K810584 · 1981-05-13

ApplicantPharmacia, Inc.
Decision Date1981-05-13
Product CodeCIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHADEBAS ISOAMYLASE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1981-05-13 under 510(k) number K810584. The device is classified under product code CIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHADEBAS ISOAMYLASE TEST?

PHADEBAS ISOAMYLASE TEST is a medical device that received FDA 510(k) clearance on 1981-05-13. The listed applicant is Pharmacia, Inc.. The 510(k) number is K810584.

When did PHADEBAS ISOAMYLASE TEST receive FDA 510(k) clearance?

PHADEBAS ISOAMYLASE TEST received FDA 510(k) clearance on 1981-05-13, under 510(k) number K810584.

Who is the listed applicant for PHADEBAS ISOAMYLASE TEST?

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

What is the FDA product code for PHADEBAS ISOAMYLASE TEST?

The FDA product code for PHADEBAS ISOAMYLASE TEST is CIW.

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 Pharmacia, Inc. 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.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

View all 129 devices →

Related Devices (Code: CIW)

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.

K931559DMA AMYLASE PROCEDUREData Medical Associates, Inc.K924339OLYMPUS AMYLASE REAGENTOlympus Corp.K884382AMYLASE TEST (AMYL) ITEM NUMBER: 65653Em Diagnostic Systems, Inc.K850639ENZYMATIC ALPHA-AMYLASE REAGENT KITBio-Analytics Laboratories, Inc.K812027KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)Eastman Kodak CompanyK810669PANTRAK E.K.Calbiochem-Behring Corp.

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.

↑