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FDA 510(k)

L-15 MEDIUM (MODIFIED)

K-Number: K810771 · 1981-05-13

ApplicantDutchland Laboratories, Inc.
Decision Date1981-05-13
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

L-15 MEDIUM (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1981-05-13 under 510(k) number K810771. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L-15 MEDIUM (MODIFIED)?

L-15 MEDIUM (MODIFIED) is a medical device that received FDA 510(k) clearance on 1981-05-13. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K810771.

When did L-15 MEDIUM (MODIFIED) receive FDA 510(k) clearance?

L-15 MEDIUM (MODIFIED) received FDA 510(k) clearance on 1981-05-13, under 510(k) number K810771.

Who is the listed applicant for L-15 MEDIUM (MODIFIED)?

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

What is the FDA product code for L-15 MEDIUM (MODIFIED)?

The FDA product code for L-15 MEDIUM (MODIFIED) is KIT.

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Related Devices (Code: KIT)

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K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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