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FDA 510(k)

HAEMOPHILUS TEST MEDIUM (HTM)

K-Number: K952595 · 1996-04-10

ApplicantClinical Standards Laboratories, Inc.
Decision Date1996-04-10
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HAEMOPHILUS TEST MEDIUM (HTM) is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Standards Laboratories, Inc.. It received FDA 510(k) clearance on 1996-04-10 under 510(k) number K952595. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMOPHILUS TEST MEDIUM (HTM)?

HAEMOPHILUS TEST MEDIUM (HTM) is a medical device that received FDA 510(k) clearance on 1996-04-10. The listed applicant is Clinical Standards Laboratories, Inc.. The 510(k) number is K952595.

When did HAEMOPHILUS TEST MEDIUM (HTM) receive FDA 510(k) clearance?

HAEMOPHILUS TEST MEDIUM (HTM) received FDA 510(k) clearance on 1996-04-10, under 510(k) number K952595.

Who is the listed applicant for HAEMOPHILUS TEST MEDIUM (HTM)?

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

What is the FDA product code for HAEMOPHILUS TEST MEDIUM (HTM)?

The FDA product code for HAEMOPHILUS TEST MEDIUM (HTM) is JSO.

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Other records listing Clinical Standards 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.

K941111STREP-SURE A/E

Related Devices (Code: JSO)

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.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID MRSAbioMerieux, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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