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FDA 510(k)

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M

K-Number: K811067 · 1981-04-29

ApplicantMarion Laboratories, Inc.
Decision Date1981-04-29
Product CodeKZT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M 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 1981-04-29 under 510(k) number K811067. The device is classified under product code KZT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M?

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K811067.

When did BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M receive FDA 510(k) clearance?

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M received FDA 510(k) clearance on 1981-04-29, under 510(k) number K811067.

Who is the listed applicant for BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M?

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 BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M?

The FDA product code for BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M is KZT.

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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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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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