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)

SERUM, IGA GOAT ANTI-HUMAN ACID

K-Number: K760146 · 1976-07-20

ApplicantOxford Laboratories, Inc.
Decision Date1976-07-20
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERUM, IGA GOAT ANTI-HUMAN ACID is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Laboratories, Inc.. It received FDA 510(k) clearance on 1976-07-20 under 510(k) number K760146. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM, IGA GOAT ANTI-HUMAN ACID?

SERUM, IGA GOAT ANTI-HUMAN ACID is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is Oxford Laboratories, Inc.. The 510(k) number is K760146.

When did SERUM, IGA GOAT ANTI-HUMAN ACID receive FDA 510(k) clearance?

SERUM, IGA GOAT ANTI-HUMAN ACID received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760146.

Who is the listed applicant for SERUM, IGA GOAT ANTI-HUMAN ACID?

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

What is the FDA product code for SERUM, IGA GOAT ANTI-HUMAN ACID?

The FDA product code for SERUM, IGA GOAT ANTI-HUMAN ACID is CZP.

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 Oxford Laboratories, 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.

K780912ADJUSTABLE DISPENSORK760144SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACIDK760148SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMANK760078REAGENT, RIA TRIIODOTHYRONINE T3 (#200)K760079REAGENT, THYROXINE T4 (#210)K760147SERUM, IGM ANTI-HUMAN ACID

View all 9 devices →

Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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.

↑