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FDA 510(k)

TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS

K-Number: K861202 · 1987-01-09

ApplicantNms Pharmaceuticals, Inc.
Decision Date1987-01-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Nms Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1987-01-09 under 510(k) number K861202. 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 TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS?

TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Nms Pharmaceuticals, Inc.. The 510(k) number is K861202.

When did TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS receive FDA 510(k) clearance?

TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS received FDA 510(k) clearance on 1987-01-09, under 510(k) number K861202.

Who is the listed applicant for TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS?

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

What is the FDA product code for TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS?

The FDA product code for TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS is JJY.

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Other records listing Nms Pharmaceuticals, 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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