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FDA 510(k)

STREP SELECTIVE II

K-Number: K843193 · 1984-09-14

ApplicantRemel Co.
Decision Date1984-09-14
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREP SELECTIVE II is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K843193. 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 STREP SELECTIVE II?

STREP SELECTIVE II is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Remel Co.. The 510(k) number is K843193.

When did STREP SELECTIVE II receive FDA 510(k) clearance?

STREP SELECTIVE II received FDA 510(k) clearance on 1984-09-14, under 510(k) number K843193.

Who is the listed applicant for STREP SELECTIVE II?

The FDA 510(k) record lists Remel Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STREP SELECTIVE II?

The FDA product code for STREP SELECTIVE II is JSI.

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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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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