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FDA 510(k)

DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH

K-Number: K973677 · 1997-12-15

ApplicantSorrento Biochemical, Inc.
Decision Date1997-12-15
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN 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 1997-12-15 under 510(k) number K973677. 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 DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH?

DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH is a medical device that received FDA 510(k) clearance on 1997-12-15. The listed applicant is Sorrento Biochemical, Inc.. The 510(k) number is K973677.

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

DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH received FDA 510(k) clearance on 1997-12-15, under 510(k) number K973677.

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

The FDA product code for DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN 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.

K973676PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGHK973678ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH

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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