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FDA 510(k)

FLUOROSCAN NEONATAL

K-Number: K950415 · 1995-09-05

ApplicantIsolab, Inc.
Decision Date1995-09-05
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLUOROSCAN NEONATAL is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1995-09-05 under 510(k) number K950415. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROSCAN NEONATAL?

FLUOROSCAN NEONATAL is a medical device that received FDA 510(k) clearance on 1995-09-05. The listed applicant is Isolab, Inc.. The 510(k) number is K950415.

When did FLUOROSCAN NEONATAL receive FDA 510(k) clearance?

FLUOROSCAN NEONATAL received FDA 510(k) clearance on 1995-09-05, under 510(k) number K950415.

Who is the listed applicant for FLUOROSCAN NEONATAL?

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

What is the FDA product code for FLUOROSCAN NEONATAL?

The FDA product code for FLUOROSCAN NEONATAL is KHO.

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Other records listing Isolab, Inc. as applicant

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Related Devices (Code: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K935047AUTO DELFIAWallac OY

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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