PARA 12

Mixture, Control, White-cell And Red-cell Indices

STRECK LABORATORIES, INC.

The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para 12.

Pre-market Notification Details

• Device ID: K823498
• 510k Number: K823498
• Device Name: PARA 12
• Classification: Mixture, Control, White-cell And Red-cell Indices
• Applicant: STRECK LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: GLQ
• CFR Regulation Number: 864.8625 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-11-24
• Decision Date: 1982-12-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00380740020330	K823498	000
30844509000625	K823498	000
30844509000632	K823498	000
40844509000615	K823498	000
40844509000622	K823498	000
40844509000639	K823498	000
50844509000612	K823498	000
00844509000648	K823498	000
00844509000655	K823498	000
00844509000662	K823498	000
00844509000679	K823498	000
00380740020323	K823498	000
30844509000618	K823498	000