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FDA 510(k)

CHALLENGE TEST PACK

K-Number: K983451 · 1999-04-23

ApplicantNorth American Science Assoc., Inc.
Decision Date1999-04-23
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHALLENGE TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is North American Science Assoc., Inc.. It received FDA 510(k) clearance on 1999-04-23 under 510(k) number K983451. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHALLENGE TEST PACK?

CHALLENGE TEST PACK is a medical device that received FDA 510(k) clearance on 1999-04-23. The listed applicant is North American Science Assoc., Inc.. The 510(k) number is K983451.

When did CHALLENGE TEST PACK receive FDA 510(k) clearance?

CHALLENGE TEST PACK received FDA 510(k) clearance on 1999-04-23, under 510(k) number K983451.

Who is the listed applicant for CHALLENGE TEST PACK?

The FDA 510(k) record lists North American Science Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHALLENGE TEST PACK?

The FDA product code for CHALLENGE TEST PACK is JOJ.

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Other records listing North American Science Assoc., 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: JOJ)

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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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