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FDA 510(k)

QM2/QM300 CONTROL A PACK

K-Number: K871342 · 1987-05-21

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1987-05-21
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QM2/QM300 CONTROL A PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1987-05-21 under 510(k) number K871342. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QM2/QM300 CONTROL A PACK?

QM2/QM300 CONTROL A PACK is a medical device that received FDA 510(k) clearance on 1987-05-21. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K871342.

When did QM2/QM300 CONTROL A PACK receive FDA 510(k) clearance?

QM2/QM300 CONTROL A PACK received FDA 510(k) clearance on 1987-05-21, under 510(k) number K871342.

Who is the listed applicant for QM2/QM300 CONTROL A PACK?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QM2/QM300 CONTROL A PACK?

The FDA product code for QM2/QM300 CONTROL A PACK is JJY.

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Other records listing Kallestad Diag, A Div. of Erbamont, 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: JJY)

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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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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