510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Optina Diagnostics Inc.

Montreal Quebec, CA

OPTINA DIAGNOSTICS INC. appears in FDA device records in Montreal Quebec, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Optina Diagnostics Inc. between 2020 and 2025. The busiest year on record is 2020, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Optina Diagnostics Inc., by decision year
YearClearances
20201
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250770Optina-4C (MHRC-C1N)HKISubstantially Equivalent
K231230Optina-4C (MHRC-C1N)HKISubstantially Equivalent
K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)HKISubstantially Equivalent

Registered establishments

FDA registered establishments for Optina Diagnostics Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30146068903014606890OPTINA DIAGNOSTICS INC.8200 Decarie Blvd, Suite #220, Montreal Quebec H4P 2P5 CA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain