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FDA 510(k)

TINSDALE ENRICHMENT

K-Number: K834066 · 1984-01-04

ApplicantRemel Co.
Decision Date1984-01-04
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TINSDALE ENRICHMENT is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1984-01-04 under 510(k) number K834066. The device is classified under product code JSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINSDALE ENRICHMENT?

TINSDALE ENRICHMENT is a medical device that received FDA 510(k) clearance on 1984-01-04. The listed applicant is Remel Co.. The 510(k) number is K834066.

When did TINSDALE ENRICHMENT receive FDA 510(k) clearance?

TINSDALE ENRICHMENT received FDA 510(k) clearance on 1984-01-04, under 510(k) number K834066.

Who is the listed applicant for TINSDALE ENRICHMENT?

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 TINSDALE ENRICHMENT?

The FDA product code for TINSDALE ENRICHMENT is JSK.

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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: JSK)

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.

K881949ATS NAC-PAC SETAlpha-Tec Systems, Inc.K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42Alpha-Tec Systems, Inc.K881566HEMOGLOBIN POWDERAcumedia Manufacturers, Inc.K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTUREHazleton Research Products, Inc.K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEFlow Laboratories, Inc.K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)Flow Laboratories, 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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