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FDA 510(k)

SUGAR-CHEX II

K-Number: K851043 · 1985-04-29

ApplicantStreck Laboratories, Inc.
Decision Date1985-04-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUGAR-CHEX II is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851043. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUGAR-CHEX II?

SUGAR-CHEX II is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K851043.

When did SUGAR-CHEX II receive FDA 510(k) clearance?

SUGAR-CHEX II received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851043.

Who is the listed applicant for SUGAR-CHEX II?

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

What is the FDA product code for SUGAR-CHEX II?

The FDA product code for SUGAR-CHEX II is JJX.

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Other records listing Streck Laboratories, Inc. as applicant

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Related Devices (Code: JJX)

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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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