Product code KDT
- Device name
- Container, Specimen Mailer And Storage, Sterile
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3250
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K873593 | BIOSURE SPECIMEN COLLECTION CONTAINER | Biosure, Inc. | 1987-11-25 |
| K862665 | NOVACYTE-U | Xsirius Medical, Inc. | 1986-09-04 |
| K834579 | BIOSPAL 2400S | Hospal Medical Corp. | 1984-02-04 |
| K834412 | PRESERV PVA FIXATIVE 15ML-FORMALIN PK | Preventive Diagnostics Corp. | 1984-01-13 |
| K833660 | PRESERV PVA FIXATIVE -MALIN PACK | Preventive Diagnostics Corp. | 1983-11-28 |
| K823773 | PROVIAL II #006-010-0201 | Dynatech Corp. | 1983-01-21 |
| K822870 | STOOL-COLLECTION/PRESERVATION KIT | American Scientific Products | 1982-11-01 |
| K821621 | PREGNOPOST | M.M. Wolfred, Ph.D. | 1982-07-21 |
| K820246 | PREFILLED SPECIMEN CONTAINER | Sage Products, Inc. | 1982-02-18 |
| K811793 | FIX-RIGHT 90ML & 180 ML PREFILLED CONT | Richard-Allan Medical Ind., Inc. | 1981-07-31 |
| K800946 | URINARY CATHETER SAMPLING KIT | Sage Products, Inc. | 1980-06-20 |
| K770071 | PINLOCK CONTAINER | Perkins Mfg. Co. | 1977-02-24 |
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|---|---|---|---|
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| 10809160466940 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2025-05-15 |
| 10198459217074 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2024-12-22 |
| 14039943000238 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
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| 14039943000214 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
| 14039943000207 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
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| 14039943000184 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
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| 14039943000122 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
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| 14039943000092 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
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| 14039943000047 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
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| 14039943000023 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
| 14039943000016 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
| 10809160345290 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2021-02-10 |
| 10809160204313 | MEDICAL ACTION INDUSTRIES | MEDICAL ACTION INDUSTRIES INC. | 2018-08-09 |
| 10887488290713 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2017-02-04 |
| 10887488636450 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-12-24 |
| 10809160002445 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |