510(k) K771201
- Device
- FORMALIN BUFFER CONCENTRATE
- Applicant
- Central Labs. Assoc. MD Pathologists
- 510(k) number
- K771201
- Product code
- IGG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-22
- Date received
- 1977-07-05
- Regulation
- 864.4010
- Classification name
- Formaldehyde (Formalin, Formol)
- Medical specialty
- Pathology
- Review panel
- Pathology
- 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#
- 3006365273
- 3017970519
- 2247035
- 3009432145
- 1045125
- 2013736
- 3010194621
- 1625587
- 1419699
- 3007496191
- 1419341
- 1831338
- 1524213
- 1640981
- 1125908
- 3009963993
- 2244900
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IGG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882268 | ZINC FORMALIN CONCENTRATE | Anatech, Ltd. | 1988-06-15 |
| K861201 | FORMALDEHYDE SOLUTION, 37% | Surgipath Medical Industries, Inc. | 1986-04-11 |
| K811794 | 37% FORMALDEHYDE | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| K802506 | PLEASCENT OR FORMA-SCENT | Meridian Diagnostics, Inc. | 1980-11-12 |
| K792705 | PARA-PAK FORMALIN | Meridian Diagnostics, Inc. | 1980-01-21 |
| K792707 | PARA-PAK SAF | Meridian Diagnostics, Inc. | 1980-01-21 |