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FDA 510(k)

DIABETES RISK DETECTOR

K-Number: K864544 · 1987-07-27

ApplicantPearce Clinical Laboratories, Inc.
Decision Date1987-07-27
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIABETES RISK DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Pearce Clinical Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-27 under 510(k) number K864544. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIABETES RISK DETECTOR?

DIABETES RISK DETECTOR is a medical device that received FDA 510(k) clearance on 1987-07-27. The listed applicant is Pearce Clinical Laboratories, Inc.. The 510(k) number is K864544.

When did DIABETES RISK DETECTOR receive FDA 510(k) clearance?

DIABETES RISK DETECTOR received FDA 510(k) clearance on 1987-07-27, under 510(k) number K864544.

Who is the listed applicant for DIABETES RISK DETECTOR?

The FDA 510(k) record lists Pearce Clinical Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIABETES RISK DETECTOR?

The FDA product code for DIABETES RISK DETECTOR is JIL.

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Other records listing Pearce Clinical Laboratories, Inc. as applicant

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Related Devices (Code: JIL)

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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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