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FDA 510(k)

RETIC-CHEX FOR CELL-DYN

K-Number: K042587 · 2004-10-19

ApplicantStreck Laboratories, Inc.
Decision Date2004-10-19
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RETIC-CHEX FOR CELL-DYN 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 2004-10-19 under 510(k) number K042587. 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 RETIC-CHEX FOR CELL-DYN?

RETIC-CHEX FOR CELL-DYN is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K042587.

When did RETIC-CHEX FOR CELL-DYN receive FDA 510(k) clearance?

RETIC-CHEX FOR CELL-DYN received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042587.

Who is the listed applicant for RETIC-CHEX FOR CELL-DYN?

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 RETIC-CHEX FOR CELL-DYN?

The FDA product code for RETIC-CHEX FOR CELL-DYN is JPK.

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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.

K040107CYTO-CHEX BCTK040025A1C-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUSK013316SICKLE-CHEX

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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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