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FDA 510(k)

ANAEROBIC ACCU-CULSHURE(TM)

K-Number: K901645 · 1990-07-16

ApplicantMedical Laboratory Automation Systems, Inc.
Decision Date1990-07-16
Product CodeJTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANAEROBIC ACCU-CULSHURE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laboratory Automation Systems, Inc.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K901645. 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 ANAEROBIC ACCU-CULSHURE(TM)?

ANAEROBIC ACCU-CULSHURE(TM) is a medical device that received FDA 510(k) clearance on 1990-07-16. The listed applicant is Medical Laboratory Automation Systems, Inc.. The 510(k) number is K901645.

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

ANAEROBIC ACCU-CULSHURE(TM) received FDA 510(k) clearance on 1990-07-16, under 510(k) number K901645.

Who is the listed applicant for ANAEROBIC ACCU-CULSHURE(TM)?

The FDA 510(k) record lists Medical Laboratory Automation Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Medical Laboratory Automation Systems, 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.

K962664ELECTRA 1800C AUTOMATIC COAGULATION ANALYZERK944227ELECTRA 1400C AUTOMATIC COAGULATION ANALYZERK931206ELECTRA 1600C AUTOMATIC COAGULATION TIMERK923220THROMBIN CLOT TIME TEST PROCEDUREK903638GASTRO-INTESTINAL ACCU-CULSHURE TMK903405CHLAMYDIA ACCU-CULSHURE 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.

K897151ACUSON V328 AND C5432 TRANSDUCERSAcuson Corp.K882637ACCU-CULSHURE TMAccu-Med 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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