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FDA 510(k)

MANUALISA MICROTITRATION PLATE READER

K-Number: K823590 · 1983-02-28

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1983-02-28
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MANUALISA MICROTITRATION PLATE READER 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 1983-02-28 under 510(k) number K823590. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUALISA MICROTITRATION PLATE READER?

MANUALISA MICROTITRATION PLATE READER is a medical device that received FDA 510(k) clearance on 1983-02-28. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K823590.

When did MANUALISA MICROTITRATION PLATE READER receive FDA 510(k) clearance?

MANUALISA MICROTITRATION PLATE READER received FDA 510(k) clearance on 1983-02-28, under 510(k) number K823590.

Who is the listed applicant for MANUALISA MICROTITRATION PLATE READER?

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 MANUALISA MICROTITRATION PLATE READER?

The FDA product code for MANUALISA MICROTITRATION PLATE READER is JJQ.

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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)

View all 126 devices →

Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, Inc.

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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