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FDA 510(k)

AUTOMATED ENZYME

K-Number: K780962 · 1978-07-27

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1978-07-27
Product CodeKSK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOMATED ENZYME 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 1978-07-27 under 510(k) number K780962. The device is classified under product code KSK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED ENZYME?

AUTOMATED ENZYME is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K780962.

When did AUTOMATED ENZYME receive FDA 510(k) clearance?

AUTOMATED ENZYME received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780962.

Who is the listed applicant for AUTOMATED ENZYME?

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 AUTOMATED ENZYME?

The FDA product code for AUTOMATED ENZYME is KSK.

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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: KSK)

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.

K813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONGamma Biologicals, Inc.K813404FREEZE DRIED FICINBiological Corp. of AmericaK810803FREEZE DRIED PAPAINBiological Corp. of AmericaK760123AUTOZYMEBd Becton Dickinson Vacutainer Systems Preanalytic

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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