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FDA 510(k)

ORICULT DTM

K-Number: K802947 · 1980-12-22

ApplicantOrion Diagnostica, Inc.
Decision Date1980-12-22
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORICULT DTM is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802947. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORICULT DTM?

ORICULT DTM is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K802947.

When did ORICULT DTM receive FDA 510(k) clearance?

ORICULT DTM received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802947.

Who is the listed applicant for ORICULT DTM?

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

What is the FDA product code for ORICULT DTM?

The FDA product code for ORICULT DTM is JSI.

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Other records listing Orion Diagnostica, Inc. as applicant

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Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, 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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