Natal-Tec HPL
FDA 510(k) K811370 · Armkel, LLC
510(k) numberK811370
Submission
- Device name
- Natal-Tec HPL
- Applicant
- Armkel, LLC
Mchenry, IL, US - Received
- May 14, 1981
- Decision date
- May 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMF – Radioimmunoassay, Human Placental Lactogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1585
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944933 | Immulite (HPL) (Human Placental Plactogen)JMF · Traditional | Diagnostic Products Corp. | 03/10/1995SE |
| K840588 | Amerlex Human Placental LactogenJMF · Traditional | Amersham Corp. | 04/04/1984SE |
| K823292 | Immophase TM HPL RadioimmunoassayJMF · Traditional | Corning Medical & Scientific | 12/28/1982SE |
| K823201 | Human Placental Lactogen KitJMF · Traditional | Diagnostic Products Corp. | 11/29/1982SE |
| K802454 | Geste Follow Kit Determ. of HPLJMF · Traditional | Syn-Kit, Inc. | 11/12/1980SE |
| K791854 | Centria HPL RiaJMF · Traditional | Union Carbide Corp. | 10/01/1979SE |
| K790919 | HPL Ria KitJMF · Traditional | Technia Diagnostics , Ltd. | 06/28/1979SE |
| K782099 | Ria Test, Nordicalb HPLJMF · Traditional | Nordiclab Intl. | 01/10/1979SE |
| K771656 | Prolactin Ria Diag. KitJMF · Traditional | Abbott Laboratories | 09/22/1977SE |
| K770659 | Rialyze HPL (Ria)JMF · Traditional | Miles Laboratories, Inc. | 05/20/1977SE |
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| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K013614 | Trojan Crystal Clear LiquidNUC · Traditional | 02/01/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
Questions and answers
When was Natal-Tec HPL cleared by the FDA?
Natal-Tec HPL (K811370) received a 510(k) decision of Substantially Equivalent on May 29, 1981, 15 days after the submission was received.
What is the product code of K811370?
The FDA product code is JMF – Radioimmunoassay, Human Placental Lactogen, a Class II (moderate risk) device regulated under 21 CFR 862.1585.