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FDA 510(k)

AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM

K-Number: K811466 · 1981-06-12

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1981-06-12
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811466. 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 AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM?

AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K811466.

When did AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM receive FDA 510(k) clearance?

AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811466.

Who is the listed applicant for AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM?

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

What is the FDA product code for AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM?

The FDA product code for AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM is JJY.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

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Related Devices (Code: JJY)

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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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