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FDA 510(k)

CK/LD ISOENZYME CONTROL PROD. #ACS CT101

K-Number: K800370 · 1980-03-12

ApplicantAnalytical Control Systems, Inc.
Decision Date1980-03-12
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK/LD ISOENZYME CONTROL PROD. #ACS CT101 is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Control Systems, Inc.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800370. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK/LD ISOENZYME CONTROL PROD. #ACS CT101?

CK/LD ISOENZYME CONTROL PROD. #ACS CT101 is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K800370.

When did CK/LD ISOENZYME CONTROL PROD. #ACS CT101 receive FDA 510(k) clearance?

CK/LD ISOENZYME CONTROL PROD. #ACS CT101 received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800370.

Who is the listed applicant for CK/LD ISOENZYME CONTROL PROD. #ACS CT101?

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

What is the FDA product code for CK/LD ISOENZYME CONTROL PROD. #ACS CT101?

The FDA product code for CK/LD ISOENZYME CONTROL PROD. #ACS CT101 is JJY.

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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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