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FDA 510(k)

SPIRIT CHEMISTRY SYSTEM

K-Number: K833116 · 1983-11-07

ApplicantBaker Instructions Corp.
Decision Date1983-11-07
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIRIT CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baker Instructions Corp.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K833116. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRIT CHEMISTRY SYSTEM?

SPIRIT CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Baker Instructions Corp.. The 510(k) number is K833116.

When did SPIRIT CHEMISTRY SYSTEM receive FDA 510(k) clearance?

SPIRIT CHEMISTRY SYSTEM received FDA 510(k) clearance on 1983-11-07, under 510(k) number K833116.

Who is the listed applicant for SPIRIT CHEMISTRY SYSTEM?

The FDA 510(k) record lists Baker Instructions Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRIT CHEMISTRY SYSTEM?

The FDA product code for SPIRIT CHEMISTRY SYSTEM is JJE.

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Other records listing Baker Instructions Corp. 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.

K882612SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERK873596BAKER TDM THEOPHYLLINE ASSAYK870603SYSTEM 9000 AUTOMATED CELL COUNTERK854173UCD URINE SPECIMEN COLLECTORK850386SYSTEM 8000 CELL COUNTERK832716ENCORE CHEMISTRY ANALYZER

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Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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