PARA 4

Mixture, Hematology Quality Control

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para 4.

Pre-market Notification Details

• Device ID: K842017
• 510k Number: K842017
• Device Name: PARA 4
• Classification: Mixture, Hematology Quality Control
• Applicant: STRECK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JPK
• CFR Regulation Number: 864.8625 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-05-18
• Decision Date: 1984-06-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844509000815	K842017	000
30844509000694	K842017	000
30844509000700	K842017	000
40844509000684	K842017	000
40844509000691	K842017	000
40844509000707	K842017	000
00844509000716	K842017	000
00844509000723	K842017	000
00844509000730	K842017	000
00844509000747	K842017	000
00844509000754	K842017	000
00844509000761	K842017	000
00844509000778	K842017	000
00844509000785	K842017	000
00844509000792	K842017	000
00844509000808	K842017	000
30844509000687	K842017	000