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FDA 510(k)

LOW IONIC STRENGTH SOLUTION (LISS)

K-Number: K791113 · 1979-06-28

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1979-06-28
Product CodeKSG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LOW IONIC STRENGTH SOLUTION (LISS) is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1979-06-28 under 510(k) number K791113. 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 LOW IONIC STRENGTH SOLUTION (LISS)?

LOW IONIC STRENGTH SOLUTION (LISS) is a medical device that received FDA 510(k) clearance on 1979-06-28. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K791113.

When did LOW IONIC STRENGTH SOLUTION (LISS) receive FDA 510(k) clearance?

LOW IONIC STRENGTH SOLUTION (LISS) received FDA 510(k) clearance on 1979-06-28, under 510(k) number K791113.

Who is the listed applicant for LOW IONIC STRENGTH SOLUTION (LISS)?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW IONIC STRENGTH SOLUTION (LISS)?

The FDA product code for LOW IONIC STRENGTH SOLUTION (LISS) is KSG.

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Other records listing Hyland Therapeutic Div., Travenol 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.

K820835ALUMINA SILICA-ACTIVATED PARTIAL THROMK820192HAEMOPHILUS INFLUENZAE TYPE B ANTISERUMK812220NEPHELOMETRIC SOLID TURBIDITY STANDARDK810078Q-PAK THERAPEUTIC DRUG MONIT. CONTROL SK810077OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.K802610ALERT A,HDL-APOLIPOROTEIN A, TEST KIT

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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.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.

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