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FDA 510(k)

DC-3 FLUIDS PACK, DC-5 FLUIDS PACK

K-Number: K852595 · 1985-07-12

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1985-07-12
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DC-3 FLUIDS PACK, DC-5 FLUIDS PACK is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K852595. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DC-3 FLUIDS PACK, DC-5 FLUIDS PACK?

DC-3 FLUIDS PACK, DC-5 FLUIDS PACK is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K852595.

When did DC-3 FLUIDS PACK, DC-5 FLUIDS PACK receive FDA 510(k) clearance?

DC-3 FLUIDS PACK, DC-5 FLUIDS PACK received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852595.

Who is the listed applicant for DC-3 FLUIDS PACK, DC-5 FLUIDS PACK?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DC-3 FLUIDS PACK, DC-5 FLUIDS PACK?

The FDA product code for DC-3 FLUIDS PACK, DC-5 FLUIDS PACK is JGS.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

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Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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