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FDA 510(k)

ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42

K-Number: K881879 · 1988-05-13

Decision Date1988-05-13
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Tec Systems, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K881879. The device is classified under product code JSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42?

ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K881879.

When did ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 receive FDA 510(k) clearance?

ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 received FDA 510(k) clearance on 1988-05-13, under 510(k) number K881879.

Who is the listed applicant for ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42?

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

What is the FDA product code for ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42?

The FDA product code for ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 is JSK.

Related Clinical Trials

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.

Other records listing Alpha-Tec 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.

View all 18 devices →

Related Devices (Code: JSK)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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