Question 1

Who is the manufacturer of SAMPLING KIT?

Accepted Answer

Pharmaseal Laboratories filed the 510(k) submission for SAMPLING KIT (K801146).

Question 2

What is the FDA product code for SAMPLING KIT?

Accepted Answer

CBT. It is classified under 21 CFR 868.1100 as a Class 1 device in the Anesthesiology panel.

Question 3

When was SAMPLING KIT cleared by the FDA?

Accepted Answer

Jun 4, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for SAMPLING KIT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SAMPLING KIT?

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	K801146
Device Name	SAMPLING KIT
Applicant	Pharmaseal Laboratories
Product Code	CBT · Anesthesiology
Decision Date	Jun 4, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1100
Device Class	Class 1

SAMPLING KIT

Device Facts

Regulatory Classification

Identification