510(k) K831065
- Device
- Sectioning Aid Kit
- Applicant
- TECHNICON INSTRUMENTS CORP.
- 510(k) number
- K831065
- Product code
- KEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-08
- Date received
- 1983-04-04
- Regulation
- 864.3010
- Classification name
- Slides, Microscope
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3012911667
- 3007123908
- 3034669683
- 3007480628
- 3030626857
- 3017231740
- 3008007472
- 3009963993
- 3017356406
- 1220502
- 3009034535
- 1640981
- 3010131137
- 3019387954
- 3013500651
- 3010781643
- 1054811
- 3009189893
- 3005787343
- 2320762
- 1054241
- 3008496560
- 3015167933
- 3010973832
- 3005273623
- 3007496191
- 3015505238
- 2022807
- 9615162
- 9680836
- 8010388
- 3016438761
- 3006330030
- 3013059683
- 3010726901
- 2024311
- 3034205711
- 1000469910
- 1043214
- 3007478714
- 3006191977
- 3011496777
- 3044466317
- 2027062
- 1627497
- 3009288740
- 8044093
- 3021013122
- 3010889828
- 3011676045
- 2432235
- 3004594181
- 3013557562
- 1055236
- 3008773547
- 3009488612
- 3005333358
- 2531335
- 2244900
- 3002805583
- 9710094
- 3002809144
- 1417592
- 3010273861
- 1419341
- 3014421917
- 2029275
- 3009176340
- 3004593486
- 3003423869
- 3008776165
- 1423537
- 2025606
- 3004488394
- 3010152370
- 3016788237
- 2083544
- 3006897996
- 2028492
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KEW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891604 | THE CEN-SLIDE(TM) CENTRIFUGE TUBE | Davstar California, Inc. | 1989-06-16 |
| K890042 | MICROSCOPE SLIDES PRECOATED | Stat Path | 1989-01-13 |
| K882357 | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY | Stat Path | 1988-06-16 |
| K820100 | FROSTED GLASS SLIDES | Stan-Pak Ent. | 1982-03-04 |
| K813242 | QUANTIMETRIC 2 TEST KIT | Kallestad Laboratories, Inc. | 1981-12-02 |
| K800232 | ABCO ULTRA SLIDE MICROSCOPE SLIDE | Abco Dealers, Inc. | 1980-02-21 |
| K760278 | SLIDE, LAB-TEK COVERED MICRO | Miles Laboratories, Inc. | 1976-08-30 |