510(k) K070062
- Device
- COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
- Applicant
- DIESSE DIAGNOSTICA SENESE S.P.A
- 510(k) number
- K070062
- Product code
- LIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-07-30
- Date received
- 2007-01-05
- Regulation
- 866.2900
- Classification name
- Device, Specimen Collection
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- RAUL ALVAREZ
- Address
- 1690 W 38 Pl. Unit B1 Hialeah FL US 33012 33012
FDA Registration Numbers#
- 1043646
- 9610649
- 3010132111
- 1220477
- 3013160357
- 8020315
- 3008132411
- 2436875
- 3014662855
- 3010131578
- 3002444944
- 9680143
- 9681465
- 1915484
- 3003742580
- 2029275
- 2243471
- 1216735
- 3013557562
- 3005739529
- 3005248192
- 1924669
- 3017830316
- 2647876
- 3017063217
- 3010407203
- 2025773
- 3022474803
- 3010155648
- 3003750284
- 8020040
- 2024800
- 8022032
- 1054241
- 1043214
- 3019837962
- 2013736
- 1055236
- 3018348
- 2320762
- 3016587486
- 1119779
- 2183744
- 9613662
Source Documents#
Other 510(k) Records For Product Code LIO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | 2024-03-27 |
| K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM | Puritan Medical Products, LLC | 2013-10-21 |
| K120846 | TRANSPORT CULTURE MEDIUM DEVICE | Puritan Medical Products, LLC | 2012-06-08 |
| K103805 | MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE | Medical Wire & Equipment Company (Bath), Ltd. | 2011-01-25 |
| K082472 | VIROCULT, MODEL MW950 | Medical Wire & Equipment Company (Bath), Ltd. | 2008-12-30 |
| K013711 | BACTI-SWAB DRY | Remel Co. | 2001-11-26 |
| K003761 | NAT - NUCLEIC ACID TRANSPORT | Medical Packaging Corp. | 2001-05-31 |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Hdc Corp. | 1999-03-15 |
| K981391 | PAR-ONE | Remel, Inc. | 1998-07-14 |
| K964144 | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF | Para Scientific Co. | 1996-11-27 |
| K963986 | STP SYSTEM PVA WITH ZINC | Sage Products, Inc. | 1996-11-08 |
| K964026 | STP SYSTEM - SAF | Sage Products, Inc. | 1996-11-07 |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Sage Products, Inc. | 1996-11-01 |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Starplex Scientific, Inc. | 1996-04-03 |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Trinity Laboratories, Inc. | 1995-11-16 |
Legacy Summary#
summary
FDA Review#
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