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)

HUMAN REFERENCE SERUM

K-Number: K770965 · 1977-06-22

ApplicantKallestad Laboratories, Inc.
Decision Date1977-06-22
Product Code
DecisionSubstantially Equivalent

Device Summary

HUMAN REFERENCE SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1977-06-22 under 510(k) number K770965. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN REFERENCE SERUM?

HUMAN REFERENCE SERUM is a medical device that received FDA 510(k) clearance on 1977-06-22. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K770965.

When did HUMAN REFERENCE SERUM receive FDA 510(k) clearance?

HUMAN REFERENCE SERUM received FDA 510(k) clearance on 1977-06-22, under 510(k) number K770965.

Who is the listed applicant for HUMAN REFERENCE SERUM?

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

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 Kallestad 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

View all 92 devices →

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.

↑