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FDA 510(k)

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR

K-Number: K930477 · 1993-06-07

ApplicantAnalytical Control Systems, Inc.
Decision Date1993-06-07
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR 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 1993-06-07 under 510(k) number K930477. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR?

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR is a medical device that received FDA 510(k) clearance on 1993-06-07. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K930477.

When did ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR receive FDA 510(k) clearance?

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR received FDA 510(k) clearance on 1993-06-07, under 510(k) number K930477.

Who is the listed applicant for ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR?

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 ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR?

The FDA product code for ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR is JIS.

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Other records listing Analytical Control Systems, Inc. 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.

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Related Devices (Code: JIS)

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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