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FDA 510(k)

SCS-1000 (SYSMEX CALIBRATOR SYSTEM)

K-Number: K943268 · 1994-12-15

ApplicantStreck Laboratories, Inc.
Decision Date1994-12-15
Product CodeKSA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SCS-1000 (SYSMEX CALIBRATOR SYSTEM) 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 1994-12-15 under 510(k) number K943268. The device is classified under product code KSA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCS-1000 (SYSMEX CALIBRATOR SYSTEM)?

SCS-1000 (SYSMEX CALIBRATOR SYSTEM) is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K943268.

When did SCS-1000 (SYSMEX CALIBRATOR SYSTEM) receive FDA 510(k) clearance?

SCS-1000 (SYSMEX CALIBRATOR SYSTEM) received FDA 510(k) clearance on 1994-12-15, under 510(k) number K943268.

Who is the listed applicant for SCS-1000 (SYSMEX CALIBRATOR SYSTEM)?

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 SCS-1000 (SYSMEX CALIBRATOR SYSTEM)?

The FDA product code for SCS-1000 (SYSMEX CALIBRATOR SYSTEM) is KSA.

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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: KSA)

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.

K897060CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLER&D Systems, Inc.K881161TECH-CAL(TM)/MULTIPLER&D Systems, Inc.K864664H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORSTechnicon Instruments Corp.K854823CBC-CAL/MULTIPLER&D Systems, Inc.K844708TRI-COUNT CALIBRATORHematology Marketing Assoc.K813530HEMOTOLOGY CALIBRATORAmerican Dade

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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