FDA 510(k)

ANTISERUM TO HUMAN HEMOPEXIN

K-Number: K790713 · 1979-09-04

Decision Date1979-09-04

Product CodeCZX

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

ANTISERUM TO HUMAN HEMOPEXIN is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K790713. The device is classified under product code CZX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERUM TO HUMAN HEMOPEXIN?

ANTISERUM TO HUMAN HEMOPEXIN is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K790713.

When did ANTISERUM TO HUMAN HEMOPEXIN receive FDA 510(k) clearance?

ANTISERUM TO HUMAN HEMOPEXIN received FDA 510(k) clearance on 1979-09-04, under 510(k) number K790713.

Who is the listed applicant for ANTISERUM TO HUMAN HEMOPEXIN?

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

What is the FDA product code for ANTISERUM TO HUMAN HEMOPEXIN?

The FDA product code for ANTISERUM TO HUMAN HEMOPEXIN is CZX.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kent Laboratories, Inc. as applicant

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KIT K951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT K950102HUMAN C-5 RADIAL IMMUNODIFFUSION KIT K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

View all 40 devices →

Related Devices (Code: CZX)

K801432HEMOPEXIN NEPHELOMETRIC ASSAYJ.T. Baker Chemical Co.K780250HEMOPEXIN NEPHELOMETRIC ASSAYSKallestad Laboratories, Inc.

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.