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FDA 510(k)

CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET

K-Number: K852461 · 1985-07-12

ApplicantMedical Analysis Systems, Inc.
Decision Date1985-07-12
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K852461. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET?

CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K852461.

When did CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET receive FDA 510(k) clearance?

CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852461.

Who is the listed applicant for CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET?

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

What is the FDA product code for CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET?

The FDA product code for CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET is JIT.

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Related Devices (Code: JIT)

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.

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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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