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FDA 510(k)

CAPINTEC CRC 35R

K-Number: K935539 · 1994-02-18

ApplicantCapintec Instruments, Inc.
Decision Date1994-02-18
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAPINTEC CRC 35R is the device name listed in this FDA 510(k) record. The listed applicant is Capintec Instruments, Inc.. It received FDA 510(k) clearance on 1994-02-18 under 510(k) number K935539. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPINTEC CRC 35R?

CAPINTEC CRC 35R is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Capintec Instruments, Inc.. The 510(k) number is K935539.

When did CAPINTEC CRC 35R receive FDA 510(k) clearance?

CAPINTEC CRC 35R received FDA 510(k) clearance on 1994-02-18, under 510(k) number K935539.

Who is the listed applicant for CAPINTEC CRC 35R?

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

What is the FDA product code for CAPINTEC CRC 35R?

The FDA product code for CAPINTEC CRC 35R is KPT. This falls under the In Vitro Diagnostics category.

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Other records listing Capintec Instruments, 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.

K943072BETA C COUNTERK930962CAPTUS 2000 WEL COUNTERK924586CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWAREK921428CAPTUS 500K910020CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELSK905796DOSE CALIBRATOR

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Related Devices (Code: KPT)

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.

K192199CRC PC Smart Chamber K1Capintec, Inc.K162394CRC-77tHRCapintec, Inc.K101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWCapintec, Inc.K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.K042746PET-DOSEComecer S.R.L.

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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