510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JHJClass II

Agglutination Method, Human Chorionic Gonadotropin

21 CFR 862.1155 / Clinical Chemistry
FDA source (opens on fda.gov)

JHJ is the FDA product code for Agglutination Method, Human Chorionic Gonadotropin, a class II device type, regulated under 21 CFR 862.1155. As of , FDA records hold 96 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
JHJ
Device name
Agglutination Method, Human Chorionic Gonadotropin
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
96
Ingested recalls
3

Clearances, product code JHJ

By decision year
96 clearances under product code JHJ with a decision year between 1977 and 1997, 1983 the highest year at 21.
Show the numbers
510(k) clearances under FDA product code JHJ by decision year
YearClearances
19771
19781
197910
19809
19819
19823
198321
198412
19857
19869
19871
19886
19911
19921
19932
19941
19961
19971

Applicants with the most clearances

Product code JHJ
Applicants holding the most 510(k) clearances under product code JHJ
ApplicantClearances
Organon LLC11
Armkel, LLC6
Stanbio Laboratory4
Cal-Tech Diagnostics, Inc.3
Diagnostic Technology, Inc.3
Immunostics, Inc.3
Intl. Diagnostic, Inc.3
Monoclonal Antibodies, Inc.3
Texas Immunology, Inc.3
Ampcor, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code