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FDA 510(k)

CALIBRATION REFERENCE I & II

K-Number: K855035 · 1986-03-17

ApplicantIntegrated Medical Systems Int'L., Inc.
Decision Date1986-03-17
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALIBRATION REFERENCE I & II is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Medical Systems Int'L., Inc.. It received FDA 510(k) clearance on 1986-03-17 under 510(k) number K855035. 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 CALIBRATION REFERENCE I & II?

CALIBRATION REFERENCE I & II is a medical device that received FDA 510(k) clearance on 1986-03-17. The listed applicant is Integrated Medical Systems Int'L., Inc.. The 510(k) number is K855035.

When did CALIBRATION REFERENCE I & II receive FDA 510(k) clearance?

CALIBRATION REFERENCE I & II received FDA 510(k) clearance on 1986-03-17, under 510(k) number K855035.

Who is the listed applicant for CALIBRATION REFERENCE I & II?

The FDA 510(k) record lists Integrated Medical Systems Int'L., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALIBRATION REFERENCE I & II?

The FDA product code for CALIBRATION REFERENCE I & II 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 Integrated Medical Systems Int'L., 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.

K855036CHEMISTRY CONTROL N & A

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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