Urine Sample Kit
FDA 510(k) K780336 · American Hospital Supply Corp.
510(k) numberK780336
Submission
- Device name
- Urine Sample Kit
- Applicant
- American Hospital Supply Corp.
Mchenry, IL, US - Received
- February 28, 1978
- Decision date
- April 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | Covidien | 04/16/2008SE |
| K011514 | Instruments for One Time Use - DisposableKDD · Traditional | Kencap , Ltd. | 08/13/2001SE |
| K971317 | National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional | National Healthcare Mfg. Corp. | 05/08/1997SE |
| K960456 | Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional | Denver Biomaterials, Inc. | 04/01/1996SE |
| K936255 | Custom CV PackKDD · Traditional | Associated Medical | 03/31/1994SN |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | Associated Medical Products Co. | 07/09/1993SESK |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K925905 | Kit, Surgical Instrument, DisposableKDD · Traditional | Kay Medical Concepts | 06/16/1993SESK |
| K924958 | Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional | Medical Insights, Inc. | 06/07/1993SEKD |
| K925215 | Sterile Surgical Instrument TraysKDD · Traditional | American Healthcare Supply Co., Inc. | 06/01/1993SEKD |
More from American Healthcare Supply Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K854739 | American Sterile Surgical Absorbent Towel · Traditional | 12/27/1985SE |
| K854759 | American Sterile Mayo Stand Tray · Traditional | 12/17/1985SE |
| K832826 | Aap Dosimetry Release or Basin SetsFNY · Traditional | 04/23/1984SE |
| K830546 | Dosimetric ReleaseKQT · Traditional | 05/25/1983SE |
| K822990 | Convertors Primary Wound Dressing IIFRO · Traditional | 04/12/1983SE |
| K830343 | Container W/Priming SolutionKDP · Traditional | 03/17/1983SE |
| K830301 | Stratus Fluorometric Enzyme IMMUN0-JJE · Traditional | 02/25/1983SE |
| K822755 | Latex Penrose Tubing · Traditional | 01/21/1983SE |
| K823418 | Heyer-Schute Universal Ureteral StentLJE · Traditional | 12/03/1982SE |
| K822966 | Convertors Disposable Dressing SpongeNAB · Traditional | 11/05/1982SE |
Questions and answers
When was Urine Sample Kit cleared by the FDA?
Urine Sample Kit (K780336) received a 510(k) decision of Substantially Equivalent on April 3, 1978, 34 days after the submission was received.
What is the product code of K780336?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.