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FDA 510(k)

HEMATO-CHEX

K-Number: K800361 · 1980-04-04

ApplicantStreck Laboratories, Inc.
Decision Date1980-04-04
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATO-CHEX 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 1980-04-04 under 510(k) number K800361. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATO-CHEX?

HEMATO-CHEX is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K800361.

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

HEMATO-CHEX received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800361.

Who is the listed applicant for HEMATO-CHEX?

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 HEMATO-CHEX?

The FDA product code for HEMATO-CHEX is JPK.

Related Clinical Trials

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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: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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