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FDA 510(k)

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU

K-Number: K851990 · 1985-06-25

ApplicantAlpkem Corp.
Decision Date1985-06-25
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K851990. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU?

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Alpkem Corp.. The 510(k) number is K851990.

When did INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU receive FDA 510(k) clearance?

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU received FDA 510(k) clearance on 1985-06-25, under 510(k) number K851990.

Who is the listed applicant for INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU?

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

What is the FDA product code for INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU?

The FDA product code for INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU is JIX.

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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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