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FDA 510(k)

XE CHECK

K-Number: K994388 · 2000-01-14

ApplicantStreck Laboratories, Inc.
Decision Date2000-01-14
Product CodeGLQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

XE CHECK 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 2000-01-14 under 510(k) number K994388. The device is classified under product code GLQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XE CHECK?

XE CHECK is a medical device that received FDA 510(k) clearance on 2000-01-14. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K994388.

When did XE CHECK receive FDA 510(k) clearance?

XE CHECK received FDA 510(k) clearance on 2000-01-14, under 510(k) number K994388.

Who is the listed applicant for XE CHECK?

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 XE CHECK?

The FDA product code for XE CHECK is GLQ.

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Other records listing Streck Laboratories, 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.

K042587RETIC-CHEX FOR CELL-DYNK040107CYTO-CHEX BCTK040025A1C-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUS

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Related Devices (Code: GLQ)

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.

K111211CELL-DYN 22 PLUS CONTROLStreckK110718CELL-CHEX WITH CPPD CRYSTALSStreckK101335CELL-CHEXStreckK090137STAK-CHEX PLUS RETICSStreckK000945PARA 12 PLUS RETICSStreck Laboratories, Inc.K992887STAK-CHEX PLUS RETICSStreck Laboratories, Inc.

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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