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FDA 510(k)

OFPBL

K-Number: K860707 · 1986-03-11

ApplicantRemel Co.
Decision Date1986-03-11
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OFPBL is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1986-03-11 under 510(k) number K860707. 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 OFPBL?

OFPBL is a medical device that received FDA 510(k) clearance on 1986-03-11. The listed applicant is Remel Co.. The 510(k) number is K860707.

When did OFPBL receive FDA 510(k) clearance?

OFPBL received FDA 510(k) clearance on 1986-03-11, under 510(k) number K860707.

Who is the listed applicant for OFPBL?

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 OFPBL?

The FDA product code for OFPBL is JSI.

Related Clinical Trials

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.

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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

View all 137 devices →

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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