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FDA 510(k)

TRI-LEVEL NDI CONTROL

K-Number: K810906 · 1981-04-14

ApplicantNuclear Diagnostics, Inc.
Decision Date1981-04-14
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRI-LEVEL NDI CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810906. 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 TRI-LEVEL NDI CONTROL?

TRI-LEVEL NDI CONTROL is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K810906.

When did TRI-LEVEL NDI CONTROL receive FDA 510(k) clearance?

TRI-LEVEL NDI CONTROL received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810906.

Who is the listed applicant for TRI-LEVEL NDI CONTROL?

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

What is the FDA product code for TRI-LEVEL NDI CONTROL?

The FDA product code for TRI-LEVEL NDI CONTROL is JJY.

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Other records listing Nuclear 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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