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)

NORMLCERA

K-Number: K810268 · 1981-03-06

ApplicantMedical Specialties Laboratories
Decision Date1981-03-06
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NORMLCERA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties Laboratories. It received FDA 510(k) clearance on 1981-03-06 under 510(k) number K810268. 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 NORMLCERA?

NORMLCERA is a medical device that received FDA 510(k) clearance on 1981-03-06. The listed applicant is Medical Specialties Laboratories. The 510(k) number is K810268.

When did NORMLCERA receive FDA 510(k) clearance?

NORMLCERA received FDA 510(k) clearance on 1981-03-06, under 510(k) number K810268.

Who is the listed applicant for NORMLCERA?

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

What is the FDA product code for NORMLCERA?

The FDA product code for NORMLCERA 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

Other records listing Medical Specialties Laboratories 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.

K852643UNI-PLATEK844897HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8K840114COAGULATION FACTOR DEFICIENT PLASMAK823587UNI-CELL

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.

↑