FDA 510(k)

GOAT ANTI-RUBELLA ANTISERA

K-Number: K780010 · 1978-01-20

ApplicantNortheast Biomedical Labs., Inc.

Decision Date1978-01-20

Product CodeGOK

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GOAT ANTI-RUBELLA ANTISERA is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Biomedical Labs., Inc.. It received FDA 510(k) clearance on 1978-01-20 under 510(k) number K780010. The device is classified under product code GOK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOAT ANTI-RUBELLA ANTISERA?

GOAT ANTI-RUBELLA ANTISERA is a medical device that received FDA 510(k) clearance on 1978-01-20. The listed applicant is Northeast Biomedical Labs., Inc.. The 510(k) number is K780010.

When did GOAT ANTI-RUBELLA ANTISERA receive FDA 510(k) clearance?

GOAT ANTI-RUBELLA ANTISERA received FDA 510(k) clearance on 1978-01-20, under 510(k) number K780010.

Who is the listed applicant for GOAT ANTI-RUBELLA ANTISERA?

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

What is the FDA product code for GOAT ANTI-RUBELLA ANTISERA?

The FDA product code for GOAT ANTI-RUBELLA ANTISERA is GOK.

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 Northeast Biomedical Labs., Inc. as applicant

K780697GOAT ANTI-INFLUENZA ANTISERA ATEXAS K780696GOAT ANTIINFLUENZA ANTISERA AUSSR K780008GOAT ANTI-INFLUENZA ANTISERA K780004GOAT ANTI-INFLUENZA ANTISERA K780007GOAT ANTI-INFLUENZA ANTISERA K780009GUINEA PIG WHOLE SERUM

View all 9 devices →

Related Devices (Code: GOK)

K832228RUBASCAN LATEX CARD TESTBd Becton Dickinson Vacutainer Systems Preanalytic K810835RUBAZYME - MAbbott Laboratories K792635ANTIBODY TO RUBELLA VIRUSElectro-Nucleonics Laboratories, Inc.K792133RUBELISA TEST KITMicrobiological Assoc.K790122RUBANONOrganon, Inc.K781638RUBINDEX*DIRECT SYSTEMOrtho Diagnostics, 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.