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FDA 510(k)

BIO-BAG ENVIRONMENTAL CHAMBER (A & B)

K-Number: K791724 · 1979-10-17

ApplicantMarion Laboratories, Inc.
Decision Date1979-10-17
Product CodeJTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIO-BAG ENVIRONMENTAL CHAMBER (A & B) 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 1979-10-17 under 510(k) number K791724. The device is classified under product code JTX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-BAG ENVIRONMENTAL CHAMBER (A & B)?

BIO-BAG ENVIRONMENTAL CHAMBER (A & B) is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K791724.

When did BIO-BAG ENVIRONMENTAL CHAMBER (A & B) receive FDA 510(k) clearance?

BIO-BAG ENVIRONMENTAL CHAMBER (A & B) received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791724.

Who is the listed applicant for BIO-BAG ENVIRONMENTAL CHAMBER (A & B)?

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 ENVIRONMENTAL CHAMBER (A & B)?

The FDA product code for BIO-BAG ENVIRONMENTAL CHAMBER (A & B) is JTX.

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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: JTX)

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.

K901645ANAEROBIC ACCU-CULSHURE(TM)Medical Laboratory Automation Systems, Inc.K897151ACUSON V328 AND C5432 TRANSDUCERSAcuson Corp.K882637ACCU-CULSHURE TMAccu-Med Corp.K781376STANDARDIZE TGCL & TGCHAmerican Monitor Corp.K780159ANASWABScott Laboratories, Inc.K761241PRE-DUCED SURGI-SWAB & TRANSPORTER TUBEGibco Laboratories Life Technologies, 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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