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FDA 510(k)

CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)

K-Number: K872145 · 1987-11-13

ApplicantCryo Corp.
Decision Date1987-11-13
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) is the device name listed in this FDA 510(k) record. The listed applicant is Cryo Corp.. It received FDA 510(k) clearance on 1987-11-13 under 510(k) number K872145. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)?

CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) is a medical device that received FDA 510(k) clearance on 1987-11-13. The listed applicant is Cryo Corp.. The 510(k) number is K872145.

When did CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) receive FDA 510(k) clearance?

CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) received FDA 510(k) clearance on 1987-11-13, under 510(k) number K872145.

Who is the listed applicant for CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)?

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

What is the FDA product code for CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)?

The FDA product code for CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) is GKL.

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Other records listing Cryo Corp. 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.

K834569VENTILATORY FREQUENCY MONITORK833994PULSAIR I & II

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, 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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