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FDA 510(k)

SPECKTIN-LA TEST SET

K-Number: K961892 · 1997-03-07

ApplicantAnalytical Control Systems, Inc.
Decision Date1997-03-07
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECKTIN-LA TEST SET 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 1997-03-07 under 510(k) number K961892. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECKTIN-LA TEST SET?

SPECKTIN-LA TEST SET is a medical device that received FDA 510(k) clearance on 1997-03-07. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K961892.

When did SPECKTIN-LA TEST SET receive FDA 510(k) clearance?

SPECKTIN-LA TEST SET received FDA 510(k) clearance on 1997-03-07, under 510(k) number K961892.

Who is the listed applicant for SPECKTIN-LA TEST SET?

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 SPECKTIN-LA TEST SET?

The FDA product code for SPECKTIN-LA TEST SET is GFO.

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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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