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FDA 510(k)

RETIC-CHEX LINEARITY FOR BC

K-Number: K070199 · 2007-02-23

ApplicantStreck
Decision Date2007-02-23
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RETIC-CHEX LINEARITY FOR BC is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2007-02-23 under 510(k) number K070199. 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 FOR BC?

RETIC-CHEX LINEARITY FOR BC is a medical device that received FDA 510(k) clearance on 2007-02-23. The listed applicant is Streck. The 510(k) number is K070199.

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

RETIC-CHEX LINEARITY FOR BC received FDA 510(k) clearance on 2007-02-23, under 510(k) number K070199.

Who is the listed applicant for RETIC-CHEX LINEARITY FOR BC?

The FDA 510(k) record lists Streck as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETIC-CHEX LINEARITY FOR BC?

The FDA product code for RETIC-CHEX LINEARITY FOR BC is JPK.

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Other records listing Streck 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.

K254166MDx-Chex for BCNK231221MDx-Chex for BC-GPK231223MDx-Chex for BC-GNK170091UA-Cellular CompleteK160585XN CALK160590XN CHECK

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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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