FDA 510(k)

EM-X

K-Number: K812222 · 1981-09-23

Decision Date1981-09-23

Product CodeKSG

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

EM-X is the device name listed in this FDA 510(k) record. The listed applicant is Biological Corp. of America. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812222. The device is classified under product code KSG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EM-X?

EM-X is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Biological Corp. of America. The 510(k) number is K812222.

When did EM-X receive FDA 510(k) clearance?

EM-X received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812222.

Who is the listed applicant for EM-X?

The FDA 510(k) record lists Biological Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EM-X?

The FDA product code for EM-X is KSG.

Other records listing Biological Corp. of America 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.

K813404FREEZE DRIED FICIN K812565ELUTION SOLUTION K810803FREEZE DRIED PAPAIN K781397EM-V K760162HEMATOLOGY CONTROL

Related Devices (Code: KSG)

K812565ELUTION SOLUTIONBiological Corp. of America K800943PENTEX BOVINE ALBUMIN 30% SOLUTIONMiles Laboratories, Inc.K800189BOVINE ALBUMIN 22% & 30% SOLUTIONSGotham Biologics, Inc.K791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONOrtho Diagnostics, Inc.K791113LOW IONIC STRENGTH SOLUTION (LISS)Hyland Therapeutic Div., Travenol Laboratories K790973LO-IONGamma Biologicals, 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.