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FDA 510(k)

HEMOTEMP TM

K-Number: K802319 · 1980-10-10

ApplicantMarion Laboratories, Inc.
Decision Date1980-10-10
Product CodeKSE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTEMP TM is the device name listed in this FDA 510(k) record. The listed applicant is Marion Laboratories, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802319. The device is classified under product code KSE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOTEMP TM?

HEMOTEMP TM is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K802319.

When did HEMOTEMP TM receive FDA 510(k) clearance?

HEMOTEMP TM received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802319.

Who is the listed applicant for HEMOTEMP TM?

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

What is the FDA product code for HEMOTEMP TM?

The FDA product code for HEMOTEMP TM is KSE.

Related Clinical Trials

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Other records listing Marion Laboratories, 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.

K883391POLYMER ADHESIVE BANDAGEK875182MODIFIED LABELING FOR TOXI-LAB THC SCREENK875181MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUMK874554ENVICLUSIVE (TM)K874552ENVISAN PADK874551ENVINET(TM)

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Related Devices (Code: KSE)

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.

K884436MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85Harris Mfg. Co.K813327SEPCOR TEMPERATURE MONITORSeparation Science Corp.K800667MONITEMP BLOOD PACK TEMP. MONITORLiquid Crystal Products, 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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