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FDA 510(k)

LO-ION

K-Number: K790973 · 1979-06-15

ApplicantGamma Biologicals, Inc.
Decision Date1979-06-15
Product CodeKSG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LO-ION is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1979-06-15 under 510(k) number K790973. 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 LO-ION?

LO-ION is a medical device that received FDA 510(k) clearance on 1979-06-15. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K790973.

When did LO-ION receive FDA 510(k) clearance?

LO-ION received FDA 510(k) clearance on 1979-06-15, under 510(k) number K790973.

Who is the listed applicant for LO-ION?

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

What is the FDA product code for LO-ION?

The FDA product code for LO-ION is KSG.

Other records listing Gamma Biologicals, 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.

K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOK861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUS

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Related Devices (Code: KSG)

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.

K812565ELUTION SOLUTIONBiological Corp. of AmericaK812222EM-XBiological Corp. of AmericaK800943PENTEX 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

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.

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