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FDA 510(k)

PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH

K-Number: K973676 · 1997-12-16

ApplicantSorrento Biochemical, Inc.
Decision Date1997-12-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH is the device name listed in this FDA 510(k) record. The listed applicant is Sorrento Biochemical, Inc.. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K973676. 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 PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH?

PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Sorrento Biochemical, Inc.. The 510(k) number is K973676.

When did PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH receive FDA 510(k) clearance?

PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH received FDA 510(k) clearance on 1997-12-16, under 510(k) number K973676.

Who is the listed applicant for PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH?

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

What is the FDA product code for PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH?

The FDA product code for PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH is JJX.

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Other records listing Sorrento Biochemical, 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: JJX)

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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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