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FDA 510(k)

CROSSLAPS ELISA

K-Number: K972788 · 1998-12-22

ApplicantDevices and Diagnostics Consulting Group
Decision Date1998-12-22
Product CodeJMM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CROSSLAPS ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Devices and Diagnostics Consulting Group. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K972788. The device is classified under product code JMM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSSLAPS ELISA?

CROSSLAPS ELISA is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Devices and Diagnostics Consulting Group. The 510(k) number is K972788.

When did CROSSLAPS ELISA receive FDA 510(k) clearance?

CROSSLAPS ELISA received FDA 510(k) clearance on 1998-12-22, under 510(k) number K972788.

Who is the listed applicant for CROSSLAPS ELISA?

The FDA 510(k) record lists Devices and Diagnostics Consulting Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROSSLAPS ELISA?

The FDA product code for CROSSLAPS ELISA is JMM.

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Related Devices (Code: JMM)

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

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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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