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FDA 510(k)

LASER PLATELETCAL/MULTIPLE

K-Number: K852016 · 1985-07-09

ApplicantR&D Systems, Inc.
Decision Date1985-07-09
Product CodeKRY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LASER PLATELETCAL/MULTIPLE is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K852016. The device is classified under product code KRY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER PLATELETCAL/MULTIPLE?

LASER PLATELETCAL/MULTIPLE is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is R&D Systems, Inc.. The 510(k) number is K852016.

When did LASER PLATELETCAL/MULTIPLE receive FDA 510(k) clearance?

LASER PLATELETCAL/MULTIPLE received FDA 510(k) clearance on 1985-07-09, under 510(k) number K852016.

Who is the listed applicant for LASER PLATELETCAL/MULTIPLE?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER PLATELETCAL/MULTIPLE?

The FDA product code for LASER PLATELETCAL/MULTIPLE is KRY.

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Other records listing R&D Systems, Inc. as applicant

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Related Devices (Code: KRY)

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.

K862122S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.K843910COULTER MEAN PLATELET VOLUME CALIBRATORCoulter Electronics, Inc.K840794S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.K821851CONTROL DIAGNOSTICS PLATELET CONTROLImmunogeneticsK781601TEKNI-CALStreck Laboratories, Inc.K781133PC-CALIBRATORStreck 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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