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FDA 510(k)

TEKTALLY II

K-Number: K771580 · 1977-09-02

ApplicantScientific Products
Decision Date1977-09-02
Product CodeGKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TEKTALLY II is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Products. It received FDA 510(k) clearance on 1977-09-02 under 510(k) number K771580. The device is classified under product code GKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEKTALLY II?

TEKTALLY II is a medical device that received FDA 510(k) clearance on 1977-09-02. The listed applicant is Scientific Products. The 510(k) number is K771580.

When did TEKTALLY II receive FDA 510(k) clearance?

TEKTALLY II received FDA 510(k) clearance on 1977-09-02, under 510(k) number K771580.

Who is the listed applicant for TEKTALLY II?

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

What is the FDA product code for TEKTALLY II?

The FDA product code for TEKTALLY II is GKM.

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Related Devices (Code: GKM)

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.

K874188COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STACoulter Electronics, Inc.K854685DIGITAL-9 KEY LEUCOCYTE COUNTERFuture Impex Corp.K841026MANUAL BLOOD CELL COUNTING DEVICEInstrumentation Laboratory CO

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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