Product Code: IAF FDA class 1 21 CFR 864.1850

Wright'S Stain

Hematology

Wright's Stain is a polychromatic Romanowsky stain used in hematology to differentiate blood cell types in peripheral blood smears and bone marrow preparations, staining nuclei blue-purple and granules in varying colors to aid differential cell counting. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IAF, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

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FEI Numbers

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Basic Information

Product Code: IAF
Device Class: FDA class 1
Regulation Number: 864.1850
Medical Specialty: Hematology
Review Panel: PA
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K890674	ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET	Feb 24, 1989	Substantially Equivalent	Sigma Diagnostics, Inc.
K890673	WRIGHT-GLEMSA STAIN	Feb 24, 1989	Substantially Equivalent	Sigma Diagnostics, Inc.
K854236	HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS	Oct 10, 1986	Substantially Equivalent for Some Indications	Nms Pharmaceuticals, Inc.
K860793	CAMCO STAIN PAK	Mar 18, 1986	Substantially Equivalent	Cambridge Chemical Products, Inc.
K853241	HEMATOLOGY STAIN PACK	Aug 19, 1985	Substantially Equivalent	Fisher Scientific Co., LLC
K852138	WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S	Jun 13, 1985	Substantially Equivalent	Canyon Diagnostics, Inc.
K842744	WRIGHT STAIN	Aug 12, 1984	Substantially Equivalent	E K Ind., Inc.
K842745	WRIGHT-GIEMSA QUICK STAIN	Aug 10, 1984	Substantially Equivalent	E K Ind., Inc.
K833678	HEMATOLOGY WRIGHT'S STAIN PACK	Nov 25, 1983	Substantially Equivalent	J.S. Medical Assoc.
K833260	STAIN PACK FOR AEROSPRAY SLIDE STAINER	Oct 28, 1983	Substantially Equivalent	Wescor, Inc.
K831605	HEMATOLOGY PAK	Jun 30, 1983	Substantially Equivalent	Mercedes Scientific Co., Inc.
K830542	HEMAQUIK II STAINING SOLUTION #55961	Mar 17, 1983	Substantially Equivalent	Accra Laboratories, Inc.
K830127	QUIK-DIP BLOOD STAIN	Feb 15, 1983	Substantially Equivalent	Mercedes Scientific Co., Inc.
K822981	MIDAS 1000 WRIGHT GIEMSA STAIN #66020	Oct 27, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822980	MIDAS 1000 WRIGHT STAIN #66010	Oct 27, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821457	HEMACOUNT WRIGHTS STAIN PACK II #55952	Jun 01, 1982	Substantially Equivalent	Accra Laboratories, Inc.
K820437	AVES WRIGHT STAIN	Mar 26, 1982	Substantially Equivalent	Helena Laboratories
K812848	ACCRA LAB HEMOTOLOGY	Oct 23, 1981	Substantially Equivalent	Accra Laboratories, Inc.
K812504	ACCRA LAB WRIGHT STAIN	Sep 23, 1981	Substantially Equivalent	Accra Laboratories, Inc.
K811400	HEMAQUIK	Jun 18, 1981	Substantially Equivalent	Accra Laboratories, Inc.
K810495	STAT STAIN SET	Mar 17, 1981	Substantially Equivalent	Accra Laboratories, Inc.
K801212	WRIGHTS RAPID STAIN	May 30, 1980	Substantially Equivalent	Mcb Manufacturing Chemists, Inc.
K792497	VOLU-SOL STATIM STAIN	Dec 18, 1979	Substantially Equivalent	Volu Sol Medical Industries
K792026	WRIGHTS RAPID STAIN	Nov 13, 1979	Substantially Equivalent	Mcb Manufacturing Chemists, Inc.
K792017	VOLU-SOL STAT STAIN	Oct 30, 1979	Substantially Equivalent	Volu Sol Medical Industries
K791929	WRIGHTS RAPID STAIN	Oct 11, 1979	Substantially Equivalent	Mcb Manufacturing Chemists, Inc.
K790571	QUIK-STAIN	Apr 23, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K781587	HEMATOLOGY STAIN PACK	Oct 10, 1978	Substantially Equivalent	Bioscientific
K781384	WRIGHT RAPID STAIN	Aug 21, 1978	Substantially Equivalent	Mfg Chemists, Inc.
K781347	CAMCO QUIK STAIN II	Aug 21, 1978	Substantially Equivalent	Cambridge Chemical Products, Inc.
K770075	BIO-DYES HEMATOLOGY PHOSPHATE	Mar 22, 1977	Substantially Equivalent	Jack W. Kindberg
K770074	BIO-DYES FORTIFIED HEMATOLOGY STAIN	Mar 22, 1977	Substantially Equivalent	Jack W. Kindberg
K760027	DSP - STAIN PACK	Jul 20, 1976	Substantially Equivalent	Harleco