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FDA 510(k)

AMYLASE REAGENT CS-726

K-Number: K844168 · 1984-11-20

ApplicantFisher Scientific Co., LLC
Decision Date1984-11-20
Product CodeCJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE REAGENT CS-726 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 1984-11-20 under 510(k) number K844168. The device is classified under product code CJA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLASE REAGENT CS-726?

AMYLASE REAGENT CS-726 is a medical device that received FDA 510(k) clearance on 1984-11-20. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K844168.

When did AMYLASE REAGENT CS-726 receive FDA 510(k) clearance?

AMYLASE REAGENT CS-726 received FDA 510(k) clearance on 1984-11-20, under 510(k) number K844168.

Who is the listed applicant for AMYLASE REAGENT CS-726?

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 AMYLASE REAGENT CS-726?

The FDA product code for AMYLASE REAGENT CS-726 is CJA.

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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: CJA)

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.

K895555MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)Hichem DiagnosticsK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.K883059WAKO(TM) AUTOKIT AMYLASEWako Chemicals USA, Inc.K873520PARAMAX AMYLASE REAGENTBaxter Healthcare CorpK863052ALPHA AMYLASEJ. D. Assoc.K862640AMYLASE LTSElectro-Nucleonics 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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