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FDA 510(k)

MODEL 5500 CEAS

K-Number: K934977 · 1994-01-11

ApplicantEsa, Inc.
Decision Date1994-01-11
Product CodeCDF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 5500 CEAS is the device name listed in this FDA 510(k) record. The listed applicant is Esa, Inc.. It received FDA 510(k) clearance on 1994-01-11 under 510(k) number K934977. The device is classified under product code CDF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5500 CEAS?

MODEL 5500 CEAS is a medical device that received FDA 510(k) clearance on 1994-01-11. The listed applicant is Esa, Inc.. The 510(k) number is K934977.

When did MODEL 5500 CEAS receive FDA 510(k) clearance?

MODEL 5500 CEAS received FDA 510(k) clearance on 1994-01-11, under 510(k) number K934977.

Who is the listed applicant for MODEL 5500 CEAS?

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

What is the FDA product code for MODEL 5500 CEAS?

The FDA product code for MODEL 5500 CEAS is CDF.

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Other records listing Esa, 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.

K032199ESA PLASMA FREE METANEPHRINE ANALYSIS KITK971640LEADCARE BLOOD LEAD TESTING SYSTEMK963938MODEL 5500 CEASK931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMK903231COULOCHEM IIK864729NEUROCHEMICAL ANALYZER

View all 7 devices →

Related Devices (Code: CDF)

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.

K953077PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEMBeckman Instruments, Inc.K895288HVA EIA KIT YAMASAYamasa Shoy Co., Ltd.K895287VMA EIA KIT YAMASAYamasa Shoy Co., Ltd.K873372HVA & HOMOVANILLIC ACID BY HPLC METHODBio-RadK861962VANILMANDELIC ACID (VMA) REAGENT SETSterling Diagnostics, Inc.K861010VMA BY HPLC TEST (VANILMANDELIC ACID)Bio-Rad

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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