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FDA 510(k)

OXALATE URINE CONTROLS (NORMAL AND ELEVATED)

K-Number: K062521 · 2007-03-16

ApplicantThermo-Electron Corp.
Decision Date2007-03-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OXALATE URINE CONTROLS (NORMAL AND ELEVATED) is the device name listed in this FDA 510(k) record. The listed applicant is Thermo-Electron Corp.. It received FDA 510(k) clearance on 2007-03-16 under 510(k) number K062521. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXALATE URINE CONTROLS (NORMAL AND ELEVATED)?

OXALATE URINE CONTROLS (NORMAL AND ELEVATED) is a medical device that received FDA 510(k) clearance on 2007-03-16. The listed applicant is Thermo-Electron Corp.. The 510(k) number is K062521.

When did OXALATE URINE CONTROLS (NORMAL AND ELEVATED) receive FDA 510(k) clearance?

OXALATE URINE CONTROLS (NORMAL AND ELEVATED) received FDA 510(k) clearance on 2007-03-16, under 510(k) number K062521.

Who is the listed applicant for OXALATE URINE CONTROLS (NORMAL AND ELEVATED)?

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

What is the FDA product code for OXALATE URINE CONTROLS (NORMAL AND ELEVATED)?

The FDA product code for OXALATE URINE CONTROLS (NORMAL AND ELEVATED) is JIT.

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Other records listing Thermo-Electron 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.

K061412THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401K052056DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM

Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,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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