Fisher Diagnostics Pregnaclone Slide Pregnancy Tes
FDA 510(k) K844346 · Fisher Diagnostics
510(k) numberK844346
Submission
- Device name
- Fisher Diagnostics Pregnaclone Slide Pregnancy Tes
- Applicant
- Fisher Diagnostics
Orangeburg, NY, US - Received
- November 9, 1984
- Decision date
- March 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHJ – Agglutination Method, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972606 | Pregnacol Pregnancy TestJHJ · Traditional | Immunostics Inc., | 08/29/1997SE |
| K921968 | In Vitro Diagnostic Reagent Set, Indir. Preg. TestJHJ · Traditional | Tech-Co, Inc. | 06/28/1996SE |
| K935863 | Sas(Tm) Direct Monoclonal HCGJHJ · Traditional | Sa Scientific, Inc. | 02/24/1994SE |
| K926112 | Accutex Beta-Hcg TestJHJ · Traditional | J.S. Medical Assoc. | 07/28/1993SE |
| K930609 | Sas(Tm) Monoclonal Hcg-SlideJHJ · Traditional | Sa Scientific, Inc. | 03/29/1993SE |
| K920716 | Direct Pregnancy TestJHJ · Traditional | Tech-Co, Inc. | 03/24/1992SE |
| K910946 | Clearview HCGJHJ · Traditional | Unipath , Ltd. | 04/01/1991SE |
| K881435 | Pregnospia IIJHJ · Traditional | Organon Teknika Corp. | 05/27/1988SE |
| K880163 | Pregnancy (HCG) Card & Liquid TestJHJ · Traditional | Ampcor, Inc. | 05/17/1988SE |
| K880478 | Pregnancy Beta-Hcg Card & Liquid TestJHJ · Traditional | Ampcor, Inc. | 04/28/1988SE |
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| K070640 | Architect Stat TROPONIN-1; MyoglobinMMI · Special | 09/13/2007SE |
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| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | 01/24/2005SE |
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Questions and answers
When was Fisher Diagnostics Pregnaclone Slide Pregnancy Tes cleared by the FDA?
Fisher Diagnostics Pregnaclone Slide Pregnancy Tes (K844346) received a 510(k) decision of Substantially Equivalent on March 4, 1985, 115 days after the submission was received.
What is the product code of K844346?
The FDA product code is JHJ – Agglutination Method, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.