Immuchem Prl-Mw Elisa
FDA 510(k) K922715 · Icn Biomedicals, Inc.
510(k) numberK922715
Submission
- Device name
- Immuchem Prl-Mw Elisa
- Applicant
- Icn Biomedicals, Inc.
Costa Mesa, CA, US - Received
- June 5, 1992
- Decision date
- October 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFT – Radioimmunoassay, Prolactin (Lactogen)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1625
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | Monobind | 06/24/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/25/1997SE |
| K970188 | Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional | Sealite Sciences, Inc. | 02/20/1997SE |
| K964748 | Elecsys Prolactin AssayCFT · Traditional | Boehringer Mannheim Corp. | 01/21/1997SE |
| K960561 | DSL Active Prolactin Elisa Model 10-4500CFT · Traditional | Diagnostic Systems Laboratories, Inc. | 04/26/1996SE |
| K960060 | DSL Active Prolactin IrmaCFT · Traditional | Diagnostic Systems Laboratories, Inc. | 02/29/1996SE |
| K954680 | Access Prolactin Assay (Modification)CFT · Traditional | Bio-Rad Laboratories, Inc. | 10/20/1995SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 09/25/1995SE |
| K944698 | Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1CFT · Traditional | Organon Teknika Corp. | 03/21/1995SE |
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| K926106 | Immuchem Phe-Mw EaJNB · Traditional | 02/08/1995SE |
| K922944 | Immuchem Lh-Mw ElisaCEP · Traditional | 02/02/1993SE |
| K922376 | Icn Biomedicals Immuchem(Tm) Fsh-Mw Elisa KitCGJ · Traditional | 10/05/1992SE |
| K920442 | Immuchem Tsh-Mw ElisaJLW · Traditional | 03/18/1992SE |
| K913963 | Immuchem Neonatal Tsh-Mp ElisaJLW · Traditional | 12/13/1991SE |
| K902445 | Lympho Sep(Tm)JCF · Traditional | 08/22/1990SE |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. RiaJLX · Traditional | 02/23/1989SE |
| K881005 | Immuchem Human Chorionic Gonadotropin Hormone HCGJHI · Traditional | 05/27/1988SE |
Questions and answers
When was Immuchem Prl-Mw Elisa cleared by the FDA?
Immuchem Prl-Mw Elisa (K922715) received a 510(k) decision of Substantially Equivalent on October 5, 1992, 122 days after the submission was received.
What is the product code of K922715?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.