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FDA 510(k)

CLINICOMP R.C.I.

K-Number: K842540 · 1984-08-08

ApplicantClinicomp, Inc.
Decision Date1984-08-08
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLINICOMP R.C.I. is the device name listed in this FDA 510(k) record. The listed applicant is Clinicomp, Inc.. It received FDA 510(k) clearance on 1984-08-08 under 510(k) number K842540. 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 CLINICOMP R.C.I.?

CLINICOMP R.C.I. is a medical device that received FDA 510(k) clearance on 1984-08-08. The listed applicant is Clinicomp, Inc.. The 510(k) number is K842540.

When did CLINICOMP R.C.I. receive FDA 510(k) clearance?

CLINICOMP R.C.I. received FDA 510(k) clearance on 1984-08-08, under 510(k) number K842540.

Who is the listed applicant for CLINICOMP R.C.I.?

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

What is the FDA product code for CLINICOMP R.C.I.?

The FDA product code for CLINICOMP R.C.I. is KPT. This falls under the In Vitro Diagnostics category.

Related Clinical Trials

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.

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Other records listing Clinicomp, 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.

K931133CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISPK850838CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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