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FDA 510(k)

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III

K-Number: K860906 · 1986-05-29

ApplicantAmerican Dade
Decision Date1986-05-29
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1986-05-29 under 510(k) number K860906. 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 STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III?

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is American Dade. The 510(k) number is K860906.

When did STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III receive FDA 510(k) clearance?

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III received FDA 510(k) clearance on 1986-05-29, under 510(k) number K860906.

Who is the listed applicant for STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III?

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

What is the FDA product code for STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III?

The FDA product code for STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III is JJY.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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