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FDA 510(k)

ACCU-CULSHURE TM

K-Number: K882637 · 1988-07-06

ApplicantAccu-Med Corp.
Decision Date1988-07-06
Product CodeJTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCU-CULSHURE TM is the device name listed in this FDA 510(k) record. The listed applicant is Accu-Med Corp.. It received FDA 510(k) clearance on 1988-07-06 under 510(k) number K882637. 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 ACCU-CULSHURE TM?

ACCU-CULSHURE TM is a medical device that received FDA 510(k) clearance on 1988-07-06. The listed applicant is Accu-Med Corp.. The 510(k) number is K882637.

When did ACCU-CULSHURE TM receive FDA 510(k) clearance?

ACCU-CULSHURE TM received FDA 510(k) clearance on 1988-07-06, under 510(k) number K882637.

Who is the listed applicant for ACCU-CULSHURE TM?

The FDA 510(k) record lists Accu-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-CULSHURE TM?

The FDA product code for ACCU-CULSHURE TM is JTX.

Related Clinical Trials

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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.K791724BIO-BAG ENVIRONMENTAL CHAMBER (A & B)Marion Laboratories, Inc.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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