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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G669CNPTLS1 | Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Sterile | Corramedical Inc. | 2026-04-07 |
| 10809160466940 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2025-05-15 |
| 04066916005993 | 25 ml tube 90x 25 | Sarstedt Aktiengesellschaft & Co.KG | 2025-01-28 |
| 04066916018412 | urine cup 76x 60 | Sarstedt Aktiengesellschaft & Co.KG | 2025-01-14 |
| 10198459217074 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2024-12-22 |
| 04038917242561 | Tube 50ml, 114x28mm, PP | Sarstedt Aktiengesellschaft & Co.KG | 2024-10-16 |
| 04038917113571 | Tube 50ml, 115x28mm, PP | Sarstedt Aktiengesellschaft & Co.KG | 2024-10-07 |
| 04038917408561 | Tube 5ml, 75x13mm | Sarstedt Aktiengesellschaft & Co.KG | 2024-09-23 |
| 04038917369954 | 10ml Yellow Cap | Sarstedt Aktiengesellschaft & Co.KG | 2024-04-26 |
| 04038917113007 | Tube 15ml, 120x17mm, PS | Sarstedt Aktiengesellschaft & Co.KG | 2023-11-07 |
| 04038917565103 | Tube 15ml, 120x17mm, PP | Sarstedt Aktiengesellschaft & Co.KG | 2023-11-07 |
| 04038917112970 | Tube 15ml, 120x17mm, PS | Sarstedt Aktiengesellschaft & Co.KG | 2023-11-07 |
| 04038917238649 | Tube 25ml 90x25PP+ Cap | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-19 |
| 04038917429931 | Tube 10ml, 100x16mm, PP | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-18 |
| 04038917155472 | Set of 4 Tube 12ml 99x16mm | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-18 |
| 04038917155199 | Tube 10ml, 100x16mm, PP | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-18 |
| 04038917155144 | Tube 10ml, 100x16, PP | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-18 |
| 04038917151573 | Tube 25ml 90x25PP+Cap | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-18 |
| 04038917151528 | Tube 25ml 90x25PP+Cap | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-18 |
| 04038917389112 | Tube 10ml 100x16 PP + Cap | Sarstedt Aktiengesellschaft & Co.KG | 2023-01-18 |
| 14039943000054 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
| 14039943000047 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
| 14039943000030 | CRYO.S | Greiner Bio - One GmbH | 2022-12-06 |
| 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 |