510(k) K852138
- Device
- WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
- Applicant
- CANYON DIAGNOSTICS, INC.
- 510(k) number
- K852138
- Product code
- IAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-06-13
- Date received
- 1985-05-16
- Regulation
- 864.1850
- Classification name
- Wright's Stain
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANTHONY FALKOWSKI
- Address
- 4081 E. La Palma Ave., Unit F Anaheim CA US 92807 92807
FDA Registration Numbers#
- 2432235
- 1125908
- 1625587
- 1937990
- 1831638
- 3008650534
- 3017970519
- 1045125
- 1930126
- 1419699
- 9610140
- 3003646592
- 3004074729
- 3002805583
- 1711690
- 1938173
- 2245285
- 3009432145
- 3006365273
- 3008174888
- 3016090200
- 3009963993
- 1221433
- 2247035
- 1613616
- 1000138378
- 2013736
- 2518071
- 3014053517
- 2250039
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IAF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890674 | ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET | Sigma Diagnostics, Inc. | 1989-02-24 |
| K890673 | WRIGHT-GLEMSA STAIN | Sigma Diagnostics, Inc. | 1989-02-24 |
| K854236 | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | Nms Pharmaceuticals, Inc. | 1986-10-10 |
| K860793 | CAMCO STAIN PAK | Cambridge Chemical Products, Inc. | 1986-03-18 |
| K853241 | HEMATOLOGY STAIN PACK | Fisher Scientific Co., LLC | 1985-08-19 |
| K842744 | WRIGHT STAIN | E K Ind., Inc. | 1984-08-12 |
| K842745 | WRIGHT-GIEMSA QUICK STAIN | E K Ind., Inc. | 1984-08-10 |
| K833678 | HEMATOLOGY WRIGHT'S STAIN PACK | J.S. Medical Assoc. | 1983-11-25 |
| K833260 | STAIN PACK FOR AEROSPRAY SLIDE STAINER | Wescor, Inc. | 1983-10-28 |
| K831605 | HEMATOLOGY PAK | Mercedes Scientific Co., Inc. | 1983-06-30 |
| K830542 | HEMAQUIK II STAINING SOLUTION #55961 | Accra Laboratories, Inc. | 1983-03-17 |
| K830127 | QUIK-DIP BLOOD STAIN | Mercedes Scientific Co., Inc. | 1983-02-15 |
| K822981 | MIDAS 1000 WRIGHT GIEMSA STAIN #66020 | Emd Chemicals, Inc. | 1982-10-27 |
| K822980 | MIDAS 1000 WRIGHT STAIN #66010 | Emd Chemicals, Inc. | 1982-10-27 |
| K821457 | HEMACOUNT WRIGHTS STAIN PACK II #55952 | Accra Laboratories, Inc. | 1982-06-01 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases