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FDA 510(k)

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)

K-Number: K933862 · 1993-10-12

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1993-10-12
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K933862. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)?

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K933862.

When did ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) receive FDA 510(k) clearance?

ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) received FDA 510(k) clearance on 1993-10-12, under 510(k) number K933862.

Who is the listed applicant for ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)?

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

What is the FDA product code for ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)?

The FDA product code for ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) is JGS.

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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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