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FDA 510(k)

RETIC CHEX LINEARITY

K-Number: K000115 · 2000-03-27

ApplicantStreck Laboratories, Inc.
Decision Date2000-03-27
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RETIC CHEX LINEARITY 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 2000-03-27 under 510(k) number K000115. 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 LINEARITY?

RETIC CHEX LINEARITY is a medical device that received FDA 510(k) clearance on 2000-03-27. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K000115.

When did RETIC CHEX LINEARITY receive FDA 510(k) clearance?

RETIC CHEX LINEARITY received FDA 510(k) clearance on 2000-03-27, under 510(k) number K000115.

Who is the listed applicant for RETIC CHEX LINEARITY?

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 LINEARITY?

The FDA product code for RETIC CHEX LINEARITY 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.

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.

K160590XN CHECKStreckK160588XN CHECK BFStreckK160586XN-L CHECKStreckK160606BC-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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