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FDA 510(k)

COPPER SULFATE SOLUTION SP. GR.1.053

K-Number: K803094 · 1981-03-06

ApplicantAccra Laboratories, Inc.
Decision Date1981-03-06
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COPPER SULFATE SOLUTION SP. GR.1.053 is the device name listed in this FDA 510(k) record. The listed applicant is Accra Laboratories, Inc.. It received FDA 510(k) clearance on 1981-03-06 under 510(k) number K803094. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPPER SULFATE SOLUTION SP. GR.1.053?

COPPER SULFATE SOLUTION SP. GR.1.053 is a medical device that received FDA 510(k) clearance on 1981-03-06. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K803094.

When did COPPER SULFATE SOLUTION SP. GR.1.053 receive FDA 510(k) clearance?

COPPER SULFATE SOLUTION SP. GR.1.053 received FDA 510(k) clearance on 1981-03-06, under 510(k) number K803094.

Who is the listed applicant for COPPER SULFATE SOLUTION SP. GR.1.053?

The FDA 510(k) record lists Accra Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPPER SULFATE SOLUTION SP. GR.1.053?

The FDA product code for COPPER SULFATE SOLUTION SP. GR.1.053 is KLS.

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Other records listing Accra Laboratories, Inc. 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.

K851494TWO-STEP ACID FAST BACTERIA STAINK851493KINYOUN ACID FAST STAIN KITK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843428BIOFIXK843426EOSIN Y 1% ALCOHOLIC

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Related Devices (Code: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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