Question 1

Who is the manufacturer of COBAS CORE PROLACTIN EIA?

Accepted Answer

Roche Diagnostic Systems, Inc. filed the 510(k) submission for COBAS CORE PROLACTIN EIA (K930305).

Question 2

What is the FDA product code for COBAS CORE PROLACTIN EIA?

Accepted Answer

CFT. It is classified under 21 CFR 862.1625 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was COBAS CORE PROLACTIN EIA cleared by the FDA?

Accepted Answer

Aug 19, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for COBAS CORE PROLACTIN EIA?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like COBAS CORE PROLACTIN EIA?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K930305
Device Name	COBAS CORE PROLACTIN EIA
Applicant	Roche Diagnostic Systems, Inc.
Product Code	CFT · Clinical Chemistry
Decision Date	Aug 19, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1625
Device Class	Class 1

COBAS CORE PROLACTIN EIA

Device Facts

Regulatory Classification

Identification