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FDA 510(k)

SYSCON TURMOR MARKER CONTROL

K-Number: K955812 · 1996-03-12

ApplicantScantibodies Laboratory, Inc.
Decision Date1996-03-12
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSCON TURMOR MARKER CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Scantibodies Laboratory, Inc.. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K955812. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSCON TURMOR MARKER CONTROL?

SYSCON TURMOR MARKER CONTROL is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is Scantibodies Laboratory, Inc.. The 510(k) number is K955812.

When did SYSCON TURMOR MARKER CONTROL receive FDA 510(k) clearance?

SYSCON TURMOR MARKER CONTROL received FDA 510(k) clearance on 1996-03-12, under 510(k) number K955812.

Who is the listed applicant for SYSCON TURMOR MARKER CONTROL?

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

What is the FDA product code for SYSCON TURMOR MARKER CONTROL?

The FDA product code for SYSCON TURMOR MARKER CONTROL is JJY.

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Other records listing Scantibodies Laboratory, 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.

K060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)K060420MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002K060348MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITK051888TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013K051810WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014K051150TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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