510(k) K770792
- Device
- TUBE, STAIN, RETICULOCYTE, LARC
- Applicant
- Corning Medical & Scientific
- 510(k) number
- K770792
- Product code
- KFC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-05
- Date received
- 1977-05-02
- Regulation
- 864.1850
- Classification name
- Methylene Blue, Tissue Stain
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1125908
- 1640981
- 1625587
- 1937990
- 1831638
- 1045125
- 1930126
- 1419699
- 9610140
- 3004074729
- 3002805583
- 1711690
- 3009432145
- 3006365273
- 3008174888
- 2133714
- 2247035
- 1000138378
- 2013736
- 2250039
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KFC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K875310 | RETICULOCYTE STAIN | Sigma Diagnostics, Inc. | 1988-02-09 |
| K843919 | SPOTTEST LOEFFLER METHYLENE BLUE STAIN | Difco Laboratories, Inc. | 1984-10-30 |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | Reagent Laboratory, Inc. | 1984-09-11 |
| K842926 | METHYLENE BLUE STAIN, LOEFFLER | E K Ind., Inc. | 1984-09-11 |
| K842743 | NEW METHYLENE BLUE N | E K Ind., Inc. | 1984-08-12 |
| K831502 | NEPHROLYTE | Flaitron Laboratories, Inc. | 1983-07-18 |