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FDA 510(k)

ABC CALIBRATION VERIFIERS

K-Number: K973791 · 1997-10-14

ApplicantSc Calibrators & Controls, LLC
Decision Date1997-10-14
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABC CALIBRATION VERIFIERS is the device name listed in this FDA 510(k) record. The listed applicant is Sc Calibrators & Controls, LLC. It received FDA 510(k) clearance on 1997-10-14 under 510(k) number K973791. 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 ABC CALIBRATION VERIFIERS?

ABC CALIBRATION VERIFIERS is a medical device that received FDA 510(k) clearance on 1997-10-14. The listed applicant is Sc Calibrators & Controls, LLC. The 510(k) number is K973791.

When did ABC CALIBRATION VERIFIERS receive FDA 510(k) clearance?

ABC CALIBRATION VERIFIERS received FDA 510(k) clearance on 1997-10-14, under 510(k) number K973791.

Who is the listed applicant for ABC CALIBRATION VERIFIERS?

The FDA 510(k) record lists Sc Calibrators & Controls, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABC CALIBRATION VERIFIERS?

The FDA product code for ABC CALIBRATION VERIFIERS is JJY.

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 Sc Calibrators & Controls, LLC 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.

K982217AC/AD LINEARITY VERIFIERSK973790ABC LINEARITY VERIFIERS

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

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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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