PARA-PAK MACRO-CON
FDA 510(k) clearance K860034 · decided 1986-02-21
Clearance details
- K-number
- K860034
- Device name
- PARA-PAK MACRO-CON
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-06
- Decision date
- 1986-02-21
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- LKS
- Device class
- 1
- Regulation number
- 866.2900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PARA-PRO FC50 (K053257) | Alpha-Tec Systems, Inc. | 2006-05-12 |
| PARACON II/FECAL CONCENTRATOR II (K021420) | Para Scientific Co. | 2002-06-04 |
| PARA-PAK SPINCON (K980077) | Meridian Diagnostics, Inc. | 1998-04-02 |
| PARAKIT (K941110) | Hardy Diagnostics | 1994-05-17 |
| CON-KIT (K941129) | Medical Chemical Corp. | 1994-05-09 |
| STOOL TRANSPORT/PROCESSOR (K933370) | Sage Products, Inc. | 1994-02-17 |
| PARASAFE(R) FIXATIVE (K935316) | Scientific Device Laboratory, Inc. | 1994-02-17 |
| PARAPREP (K931849) | Medastat Scientific Corp. | 1993-12-02 |
| MODIFIED PARACON(TM) CONCENTRATION KIT (K881649) | Para Scientific Co. | 1988-04-21 |
| PARA CON TM (K853715) | Para Scientific Co. | 1985-10-02 |
| FPC FECAL PARASITE CONCENTRATOR (K833469) | Evergreen Scientific, Inc. | 1983-11-28 |
| TESTCORP ANA (K831365) | Catheter Technology Corp. | 1983-06-02 |
Recalls involving this device
No recalls on record reference this clearance.