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FDA 510(k)

BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT

K-Number: K802415 · 1980-10-31

ApplicantRemel Co.
Decision Date1980-10-31
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802415. The device is classified under product code JSG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT?

BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Remel Co.. The 510(k) number is K802415.

When did BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT receive FDA 510(k) clearance?

BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802415.

Who is the listed applicant for BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT?

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 BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT?

The FDA product code for BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT is JSG.

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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: JSG)

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.

K882495THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007Lakewood Biochemical Co., Inc.K881558TRYPTOSE AGARAcumedia Manufacturers, Inc.K881550OF BASAL MEDIUMAcumedia Manufacturers, Inc.K881557TRYPTONEAcumedia Manufacturers, Inc.K881564TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACTAcumedia Manufacturers, Inc.K881533BLOOD AGAR BASE NO. 2Acumedia 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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