510(k) K830582
- Device
- MILLONIG'S MODIFIED PHOSPHATE BUFFERED
- Applicant
- SURGIPATH MEDICAL INDUSTRIES, INC.
- 510(k) number
- K830582
- Product code
- IFP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-17
- Date received
- 1983-02-23
- Regulation
- 864.4010
- Classification name
- Formalin, Neutral Buffered
- 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#
- 3004192065
- 3007496191
- 9610140
- 1625587
- 3009963993
- 2244900
- 3030412764
- 3006365273
- 3012763559
- 1045125
- 3014579161
- 3004074729
- 8020301
- 1924669
- 1419341
- 1640981
- 2247035
- 2013736
- 3007478714
- 1419699
- 2250039
- 1063851
- 2025606
- 3016788237
- 1125908
- 2083544
- 3017970519
- 1831638
- 1711690
- 3010973832
- 1831338
- 3010194621
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IFP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884755 | CONSED FECAL CONCENTRATION SYSTEM | Donald L. Price, Ph.D. | 1989-01-10 |
| K872663 | DRY-FORM | Anatech, Ltd. | 1987-08-06 |
| K872140 | (MSI) PATH-SAVER | Medical Specialties, Inc. | 1987-06-15 |
| K870852 | NBF 10% NEUTRAL BUFFERED FORMALIN | Anatech, Ltd. | 1987-03-31 |
| K853497 | PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN | Surgipath Medical Industries, Inc. | 1985-08-28 |
| K842982 | FORMALIN BUFFERED | Reagent Laboratory, Inc. | 1984-10-01 |
| K842940 | CBA FORMALIN | Anatech, Ltd. | 1984-08-28 |
| K842728 | BUF-FIX | E K Ind., Inc. | 1984-08-03 |
| K840926 | FORMALIN SOLUTION 10% NEUTRAL BUFFER | Sigma Chemical Co. | 1984-03-12 |
| K830583 | NEUTRAL BUFFERED FORMALIN 10% | Surgipath Medical Industries, Inc. | 1983-03-17 |
| K830514 | MILLONIGS MODIFIED PHOSPHATE BUFFERED | Surgipath Medical Industries, Inc. | 1983-03-08 |
| K812940 | 10% NEUTRAL BUFFERED FORMALIN CONCENT | Surgipath | 1981-12-10 |
| K812817 | NEUTRAL DUFFERED FORMA-SCENT | Meridian Diagnostics, Inc. | 1981-11-10 |
| K811795 | 10% NEUTRAL BUFFERED FORMALDEHYDE | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
Legacy Summary#
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
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