510(k) K935316
- Device
- PARASAFE(R) FIXATIVE
- Applicant
- SCIENTIFIC DEVICE LABORATORY, INC.
- 510(k) number
- K935316
- Product code
- LKS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-17
- Date received
- 1993-11-02
- Regulation
- 866.2900
- Classification name
- Device, Parasite Concentration
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEWART LIPTON
- Address
- 508 Zenith Dr. Glenview IL US 60025 60025
FDA Registration Numbers#
- 2016673
- 2022807
- 2032839
- 2013736
- 1524213
- 2025606
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053257 | PARA-PRO FC50 | Alpha-Tec Systems, Inc. | 2006-05-12 |
| K021420 | PARACON II/FECAL CONCENTRATOR II | Para Scientific Co. | 2002-06-04 |
| K980077 | PARA-PAK SPINCON | Meridian Diagnostics, Inc. | 1998-04-02 |
| K941110 | PARAKIT | Hardy Diagnostics | 1994-05-17 |
| K941129 | CON-KIT | Medical Chemical Corp. | 1994-05-09 |
| K933370 | STOOL TRANSPORT/PROCESSOR | Sage Products, Inc. | 1994-02-17 |
| K931849 | PARAPREP | Medastat Scientific Corp. | 1993-12-02 |
| K881649 | MODIFIED PARACON(TM) CONCENTRATION KIT | Para Scientific Co. | 1988-04-21 |
| K860034 | PARA-PAK MACRO-CON | Meridian Diagnostics, Inc. | 1986-02-21 |
| K853715 | PARA CON TM | Para Scientific Co. | 1985-10-02 |
| K833469 | FPC FECAL PARASITE CONCENTRATOR | Evergreen Scientific, Inc. | 1983-11-28 |
| K831365 | TESTCORP ANA | Catheter Technology Corp. | 1983-06-02 |
Legacy Summary#
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FDA Review#
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