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FDA 510(k)

PC-CALIBRATOR

K-Number: K781133 · 1978-08-14

ApplicantStreck Laboratories, Inc.
Decision Date1978-08-14
Product CodeKRY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PC-CALIBRATOR 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 1978-08-14 under 510(k) number K781133. 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 PC-CALIBRATOR?

PC-CALIBRATOR is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K781133.

When did PC-CALIBRATOR receive FDA 510(k) clearance?

PC-CALIBRATOR received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781133.

Who is the listed applicant for PC-CALIBRATOR?

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 PC-CALIBRATOR?

The FDA product code for PC-CALIBRATOR is KRY.

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: 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.K852016LASER PLATELETCAL/MULTIPLER&D Systems, Inc.K843910COULTER MEAN PLATELET VOLUME CALIBRATORCoulter Electronics, Inc.K840794S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.K821851CONTROL DIAGNOSTICS PLATELET CONTROLImmunogeneticsK781601TEKNI-CALStreck 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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