Hematology Pak

FDA 510(k) K831605 · Mercedes Scientific Co., Inc.

Substantially Equivalent

510(k) numberK831605

Submission

Device name
Hematology Pak
Applicant
Mercedes Scientific Co., Inc.
Mchenry, IL, US
Received
May 18, 1983
Decision date
June 30, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IAF – Wright'S Stain
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code IAF

510(k)DeviceApplicantDecision
K890674Accustain(Tm) - Automated Wright Giemsa Stain SetIAF · Traditional Sigma Diagnostics, Inc.02/24/1989SE
K890673Wright-Glemsa StainIAF · Traditional Sigma Diagnostics, Inc.02/24/1989SE
K854236Histamine Ria Test for Histamine Biological FluidsIAF · Traditional Nms Pharmaceuticals, Inc.10/10/1986SN
K860793Camco Stain PakIAF · Traditional Cambridge Chemical Products, Inc.03/18/1986SE
K853241Hematology Stain PackIAF · Traditional Fisher Scientific Co., LLC08/19/1985SE
K852138Wescor Stain Pack for Model 7100 Aerospray Slide SIAF · Traditional Canyon Diagnostics, Inc.06/13/1985SE
K842744Wright StainIAF · Traditional E K Ind., Inc.08/12/1984SE
K842745Wright-Giemsa Quick StainIAF · Traditional E K Ind., Inc.08/10/1984SE
K833678Hematology Wright's Stain PackIAF · Traditional J.S. Medical Assoc.11/25/1983SE
K833260Stain Pack for Aerospray Slide StainerIAF · Traditional Wescor, Inc.10/28/1983SE

More from Wescor, Inc.

510(k)DeviceDecision
K830127Quik-Dip Blood StainIAF · Traditional 02/15/1983SE

Questions and answers

When was Hematology Pak cleared by the FDA?

Hematology Pak (K831605) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 43 days after the submission was received.

What is the product code of K831605?

The FDA product code is IAF – Wright'S Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.