Aimstick PBD Pregnancy
FDA 510(k) K974368 · Germaine Laboratories, Inc.
510(k) numberK974368
Submission
- Device name
- Aimstick PBD Pregnancy
- Applicant
- Germaine Laboratories, Inc.
San Antonio, TX, US - Received
- November 20, 1997
- Decision date
- January 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
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More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051727 | Aimstick Urine Reagent StripsCEN · Traditional | 10/26/2005SE |
| K013857 | Aimstep PregnancyDHA · Traditional | 01/22/2002SE |
| K991369 | Accudip Home Pregnancy And/Or Aimstick PregnancyLCX · Traditional | 05/10/1999SE |
| K981165 | Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 TestJHI · Traditional | 04/16/1998SE |
| K980531 | Aimstep PregnancyJHI · Traditional | 03/06/1998SE |
| K974512 | Aimstick PBD Combo PregnancyDHA · Traditional | 01/02/1998SE |
| K973825 | Midstream Home Regnancy TestDHA · Traditional | 12/19/1997SE |
Questions and answers
When was Aimstick PBD Pregnancy cleared by the FDA?
Aimstick PBD Pregnancy (K974368) received a 510(k) decision of Substantially Equivalent on January 2, 1998, 43 days after the submission was received.
What is the product code of K974368?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.