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)

ANIMAL AND HUMAN SERA

K-Number: K881287 · 1988-04-05

ApplicantCell Culture Laboratories
Decision Date1988-04-05
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANIMAL AND HUMAN SERA is the device name listed in this FDA 510(k) record. The listed applicant is Cell Culture Laboratories. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K881287. The device is classified under product code KIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANIMAL AND HUMAN SERA?

ANIMAL AND HUMAN SERA is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Cell Culture Laboratories. The 510(k) number is K881287.

When did ANIMAL AND HUMAN SERA receive FDA 510(k) clearance?

ANIMAL AND HUMAN SERA received FDA 510(k) clearance on 1988-04-05, under 510(k) number K881287.

Who is the listed applicant for ANIMAL AND HUMAN SERA?

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

What is the FDA product code for ANIMAL AND HUMAN SERA?

The FDA product code for ANIMAL AND HUMAN SERA is KIS.

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

Related Devices (Code: KIS)

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.

K880471BOVINE CALF SERUM SUPPLEMENTED #A-2159Hyclone Laboratories, Inc.K880470BOVINE CALF SERUM CATALOG #A-2119Hyclone Laboratories, Inc.K872847SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTCandace Lane Corp.K870580MLC NORMAL SERUMRjo Biologicals, Inc.K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.K870469DEFINED EQUINE SERUM #A-3311Hyclone 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.

↑