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)

ZETA-SERA D

K-Number: K812329 · 1981-09-01

ApplicantAmf Biological and Diagnostics Co.
Decision Date1981-09-01
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ZETA-SERA D is the device name listed in this FDA 510(k) record. The listed applicant is Amf Biological and Diagnostics Co.. It received FDA 510(k) clearance on 1981-09-01 under 510(k) number K812329. 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 ZETA-SERA D?

ZETA-SERA D is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Amf Biological and Diagnostics Co.. The 510(k) number is K812329.

When did ZETA-SERA D receive FDA 510(k) clearance?

ZETA-SERA D received FDA 510(k) clearance on 1981-09-01, under 510(k) number K812329.

Who is the listed applicant for ZETA-SERA D?

The FDA 510(k) record lists Amf Biological and Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZETA-SERA D?

The FDA product code for ZETA-SERA D is KIS.

Other records listing Amf Biological and Diagnostics Co. 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.

K852418QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)K821931ZETA-CORTK821553ZETAPHASE T3 UPTAKE DIAGNOSTIC KITK821554ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

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.

K881287ANIMAL AND HUMAN SERACell Culture LaboratoriesK880471BOVINE 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.

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.

↑