Question 1

Who is the manufacturer of FISHER SPECTROPHOTOMETER?

Accepted Answer

Bausch & Lomb, Inc. filed the 510(k) submission for FISHER SPECTROPHOTOMETER (K780902).

Question 2

What is the FDA product code for FISHER SPECTROPHOTOMETER?

Accepted Answer

JJQ. It is classified under 21 CFR 862.2300 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was FISHER SPECTROPHOTOMETER cleared by the FDA?

Accepted Answer

Jun 28, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for FISHER SPECTROPHOTOMETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like FISHER SPECTROPHOTOMETER?

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	K780902
Device Name	FISHER SPECTROPHOTOMETER
Applicant	Bausch & Lomb, Inc.
Product Code	JJQ · Clinical Chemistry
Decision Date	Jun 28, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2300
Device Class	Class 1

FISHER SPECTROPHOTOMETER

Device Facts

Regulatory Classification

Identification