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FDA 510(k)

L-CYSTEINE HYDROCHLORIDE

K-Number: K781690 · 1978-10-27

ApplicantFisher Scientific Co., LLC
Decision Date1978-10-27
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

L-CYSTEINE HYDROCHLORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1978-10-27 under 510(k) number K781690. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L-CYSTEINE HYDROCHLORIDE?

L-CYSTEINE HYDROCHLORIDE is a medical device that received FDA 510(k) clearance on 1978-10-27. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K781690.

When did L-CYSTEINE HYDROCHLORIDE receive FDA 510(k) clearance?

L-CYSTEINE HYDROCHLORIDE received FDA 510(k) clearance on 1978-10-27, under 510(k) number K781690.

Who is the listed applicant for L-CYSTEINE HYDROCHLORIDE?

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

What is the FDA product code for L-CYSTEINE HYDROCHLORIDE?

The FDA product code for L-CYSTEINE HYDROCHLORIDE is JHS.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, 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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