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FDA 510(k)

DROPPER, SOLUTION TRICHROME, CEPTI-SEAL

K-Number: K781062 · 1978-08-14

ApplicantMarion Laboratories, Inc.
Decision Date1978-08-14
Product CodeHYW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DROPPER, SOLUTION TRICHROME, CEPTI-SEAL 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 1978-08-14 under 510(k) number K781062. The device is classified under product code HYW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DROPPER, SOLUTION TRICHROME, CEPTI-SEAL?

DROPPER, SOLUTION TRICHROME, CEPTI-SEAL is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K781062.

When did DROPPER, SOLUTION TRICHROME, CEPTI-SEAL receive FDA 510(k) clearance?

DROPPER, SOLUTION TRICHROME, CEPTI-SEAL received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781062.

Who is the listed applicant for DROPPER, SOLUTION TRICHROME, CEPTI-SEAL?

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 DROPPER, SOLUTION TRICHROME, CEPTI-SEAL?

The FDA product code for DROPPER, SOLUTION TRICHROME, CEPTI-SEAL is HYW.

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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: HYW)

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.

K792706PARA-PAK(WHEATLEY'S TRICHROME STAIN)Meridian Diagnostics, 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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