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FDA 510(k)

ATS NAC-PAC SET

K-Number: K881949 · 1988-05-25

ApplicantAlpha-Tec Systems, Inc.
Decision Date1988-05-25
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ATS NAC-PAC SET 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 1988-05-25 under 510(k) number K881949. 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 NAC-PAC SET?

ATS NAC-PAC SET is a medical device that received FDA 510(k) clearance on 1988-05-25. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K881949.

When did ATS NAC-PAC SET receive FDA 510(k) clearance?

ATS NAC-PAC SET received FDA 510(k) clearance on 1988-05-25, under 510(k) number K881949.

Who is the listed applicant for ATS NAC-PAC SET?

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 NAC-PAC SET?

The FDA product code for ATS NAC-PAC SET is JSK.

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.

K053257PARA-PRO FC50K890861ATS DOBELL & O'CONNOR'S IODINEK890020ATS LUGOL'S IODINE SOLUTIONK890148ATS TB RAPID STAIN SET PRODUCT #034-45K890022ATS MAYER'S ALBUMINK883048ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION

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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.

K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42Alpha-Tec Systems, Inc.K881566HEMOGLOBIN POWDERAcumedia Manufacturers, Inc.K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTUREHazleton Research Products, Inc.K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)Flow Laboratories, Inc.K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEFlow Laboratories, Inc.K861823GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)Flow Laboratories, Inc.

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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