Tip Top(R) Dispenser Caps
FDA 510(k) K896670 · Helena Laboratories
510(k) numberK896670
Submission
- Device name
- Tip Top(R) Dispenser Caps
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- November 27, 1989
- Decision date
- March 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJW – Pipette, Pasteur
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6160
- Specialty
- Hematology
Other 510(k)s with product code GJW
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|---|---|---|---|
| K771138 | Pipets Borosilicate GlassGJW · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/04/1977SE |
| K771137 | Pipets Uniform Drop Size BorosilicateGJW · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/04/1977SE |
| K760899 | Sterile Disposable Cotton Plugged Ser.GJW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/09/1976SE |
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Questions and answers
When was Tip Top(R) Dispenser Caps cleared by the FDA?
Tip Top(R) Dispenser Caps (K896670) received a 510(k) decision of Substantially Equivalent on March 23, 1990, 116 days after the submission was received.
What is the product code of K896670?
The FDA product code is GJW – Pipette, Pasteur, a Class I (low risk) device regulated under 21 CFR 864.6160.