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FDA 510(k)

LIQUID CHEMISTRY CONTROL, LEVEL II

K-Number: K870683 · 1987-04-06

ApplicantU. S. Diagnostics, Inc.
Decision Date1987-04-06
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID CHEMISTRY CONTROL, LEVEL II is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-04-06 under 510(k) number K870683. 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 LIQUID CHEMISTRY CONTROL, LEVEL II?

LIQUID CHEMISTRY CONTROL, LEVEL II is a medical device that received FDA 510(k) clearance on 1987-04-06. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K870683.

When did LIQUID CHEMISTRY CONTROL, LEVEL II receive FDA 510(k) clearance?

LIQUID CHEMISTRY CONTROL, LEVEL II received FDA 510(k) clearance on 1987-04-06, under 510(k) number K870683.

Who is the listed applicant for LIQUID CHEMISTRY CONTROL, LEVEL II?

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

What is the FDA product code for LIQUID CHEMISTRY CONTROL, LEVEL II?

The FDA product code for LIQUID CHEMISTRY CONTROL, LEVEL II is JJY.

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Other records listing U. S. Diagnostics, Inc. as applicant

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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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